197 Trackwise Jobs

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

Supplier quality management. Drafting of Annual Monitoring and Certification report for materials. Drafting and Archival of Quality Assurance Agreement with Suppliers/Service providers Evaluation and Management of Supplier Change Notifications (SCN). Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers. Management of Supplier/ Material qualification and supplier related documentations. Preparation of regulatory statement for materials and finished products. Revision of Swiss Hub product list. Management of Import Licenses. Implementation and closure of Trackwise Change control actions related to Quality Assurance Agreements. Management and archival of Quality Questionnaires, QAA, QRA and Compliance (ASL, Oversight monitoring) for Country Quality. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for managing the Quality Product Compliance files for Canada and the U.S. Additionally, acts as the primary Quality contact for products which Apotex acts as a contract manufacturer. Acts as liaison between Apotex’s manufacturing sites and customer affiliates. Job Responsibilities Maintain Quality Product Compliance files for all 3rd party contract manufactured product in which Apotex is the Marketing Authorization holder or acts as a distributor for the Canadian market; this includes formally requesting annually with our vendors their current approved master documentation, stability summary reports. Follows up with vendors to ensure all documents are received. Develops and maintains Quality Product Compliance files for the US marketplace based on current GMP Regulations. Perform assigned Post implementation tasks from TrackWise. Initiate the Change Controls in TrackWise, where no RA assessment required. Tracking of confirmatory testing & batch record review (Initial launch batches and annual batches). Request and obtain vendor APRs as per the schedule on time. Maintain and track unique identifier documentation and expiry and ensure up to date. Acts as the liaison between external customers and our internal functional groups to provide customer quality requests in a timely manner. Interacts with internal functional groups including stability, quality assurance, quality control, regulatory affairs, and quality compliance for obtaining the necessary documentation and handling customer requests. Tracks open requests from customers to ensure timely responses. Escalate to senior management any significant delays. Responsible for timely compilation of batch release documents under guidance of Global External Manufacturing Quality. Responsible for timely updation of batch release tracker associated with batch release activity. Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market. Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team. Assist External Manufacturing Quality with follow up for new product launch, change control or deviations. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline. Knowledge, Skills, and Abilities Effective in communicating (speak, read and write) in English. Excellent organizational skills and the ability to manage time effectively. Strong interpersonal skills and very customer focused. Must be detail-oriented, accurate and reliable. Must be able to work independently with minimal supervision. Ability to follow instructions according to written procedures. Ability to manage multiple priorities in a fast-paced and changing environment. Knowledge of GMP and regulatory requirements. Experience One to two years of experience in a pharmaceutical environment. Familiarity with MS Word, Excel and Access is an asset. At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for managing the Quality Product Compliance files for Canada and the U.S. Additionally, acts as the primary Quality contact for products which Apotex acts as a contract manufacturer. Acts as liaison between Apotex’s manufacturing sites and customer affiliates. Job Responsibilities Maintain Quality Product Compliance files for all 3rd party contract manufactured product in which Apotex is the Marketing Authorization holder or acts as a distributor for the Canadian market; this includes formally requesting annually with our vendors their current approved master documentation, stability summary reports. Follows up with vendors to ensure all documents are received. Develops and maintains Quality Product Compliance files for the US marketplace based on current GMP Regulations. Perform assigned Post implementation tasks from TrackWise. Initiate the Change Controls in TrackWise, where no RA assessment required. Tracking of confirmatory testing & batch record review (Initial launch batches and annual batches). Request and obtain vendor APRs as per the schedule on time. Maintain and track unique identifier documentation and expiry and ensure up to date. Acts as the liaison between external customers and our internal functional groups to provide customer quality requests in a timely manner. Interacts with internal functional groups including stability, quality assurance, quality control, regulatory affairs, and quality compliance for obtaining the necessary documentation and handling customer requests. Tracks open requests from customers to ensure timely responses. Escalate to senior management any significant delays. Responsible for timely compilation of batch release documents under guidance of Global External Manufacturing Quality. Responsible for timely updation of batch release tracker associated with batch release activity. Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market. Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team. Assist External Manufacturing Quality with follow up for new product launch, change control or deviations. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline. Knowledge, Skills, and Abilities Effective in communicating (speak, read and write) in English. Excellent organizational skills and the ability to manage time effectively. Strong interpersonal skills and very customer focused. Must be detail-oriented, accurate and reliable. Must be able to work independently with minimal supervision. Ability to follow instructions according to written procedures. Ability to manage multiple priorities in a fast-paced and changing environment. Knowledge of GMP and regulatory requirements. Experience One to two years of experience in a pharmaceutical environment. Familiarity with MS Word, Excel and Access is an asset. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Date: 31 Jul 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Designation: AQA Reviewer Job Location: Bangalore Department: Analytical Quality Assurance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation . Key Responsibilities Review of analytical raw data (through ELN / manual) generated by analyst, protocols/ reports pertaining to the section as per the standard operating procedure and specification. Ensuring, verifying, and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP. Review of Outsourced analytical report. Review of logbooks with respect to all activity performed in the lab. Responsible for taking any other job allocated by Department Head / Department In charge. Review of technical data in analytical document viz. Calculations, Chromatograms, method parameters, integration, logbook entries, WS/RS and Column usage records, method parameters, reconciliation, vendor COA and other technical data in analytical document. Responsible to ensure review and release of raw material and packing material in LIMS/SAP. Responsible to ensure review and release of cleaning samples, inprocess samples, calibration reports and standard qualification reports. Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents. Review the documents for completeness, compliance to good documentation practices, test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable Review of all the tests as specified in the specification/Request for analysis /validation protocol/sampling protocol have been carried out Review of all supporting documents like chromatograms, balance print outs, Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable Review of the test results in COA against specification along with other relevant sample information before approval. In case of any discrepancy, immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory. Ensuring of conducting regular GMP rounds at Quality Control Laboratory. Involving in the Laboratory incident investigation, review, and approval. Educational Quali fi cation: M. Sc (Life science / Chemistry)/ M. Pharm Technical/functional Skills Good exposure in Enterprise Applications like SAP, Learning Management Systems, Trackwise, and Analytical laboratory Applications like Chromatography and Non-chromatography data Management. Well versed in electronic data audit review. Good Knowledge on handling the application software. Establish good Interpersonal skills with cross-functional teams. Experience: 9 to 12 Years experience in life science industry. Behavioural Skills Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team. Good speaking-listening-writing skills, attention to details, proactive self-starter. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be able to work in team and flexible for working in shifts. Should be a focused employee. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Job Description Senior Manager, Product Analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers. Role Overview As a Technical Project Manager, you will be responsible driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Applies a structured approach to discover, document, and manage business process, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Design, develop, and deploy UiPath RPA solutions to automate Quality Management System processes including document routing, compliance reporting, deviation management, and audit preparation workflows. Build and maintain low-code applications on the Appian platform to support Quality business processes, translating complex QMS requirements into process models, SAIL interfaces, CDTs, records, and reports. Integrate Appian Quality solutions with external systems including Veeva Vault Quality, TrackWise, and enterprise databases via APIs, web services, and other integration methods. Gathers insight into user journey, behavior, motivation, and pain points. Exposes unarticulated problems and unmet needs. Documents business process, business, and user needs in the form of problem statements to make up the backlog. Facilitates the “how” with the Development team. Gains expertise in the business area Manage business analysis per agreed priority backlog items in JIRA. Participate in impact assessment activities, reviewing proposed changes and ensuring impact understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolves to meet business needs Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan and implementation. Initiate projects including defining a scope/charter, identify stakeholders, and establish governance. Act as a bridge between Business SMEs, technical teams and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required -Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background on how Information Technology supports the delivery of business objectives Preferred Level of Education - Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 7+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding of Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management) Experience in solution delivery with GMP systems Experience with UiPath RPA development including bot creation, workflow orchestration, exception handling, and deployment in GxP-regulated environments with validation documentation requirements. Proficiency in Appian low-code platform development including process modeling, SAIL interface design, data integration with external databases (SQL, Oracle), and API connectivity for Quality system implementations. Experience with architecture, integration, interfaces, portals, and/or analytics Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes Knowledge and experience with QMS relevant tools like Veeva Vault Quality, Track wise Proven experience in leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities. Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation. Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 08/8/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R352364

Job Description Manager Product analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Business, Management Process, Management System Development, Product Lifecycle, Product Management, Quality Management, Requirements Management, Social Collaboration, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 08/23/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R350703

Job Description Manager Product Analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 08/23/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R352361

Job Description Manager Product Analyst – Quality The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products. Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats. Our Technology centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of the company's IT operating model, Tech centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy. A focused group of leaders in each tech center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share the best practices across the Tech Centers. Role Overview As a Sr Specialist, Product Analyst – Quality, you will be responsible for driving solution design, implementation, and continuous improvement of the different QMS tools with specific alignment to the Quality business processes. Essential skills include a strong technical as well as business background, proficiency in project management methodologies (Agile, Scrum), and excellent organizational abilities. This role is positioned within the Quality Value Team, will have advanced experience in the life sciences industry, specifically Quality Management Systems and technology landscapes; specifically, Veeva Vault Quality; will have knowledge of GxP and will play a critical role during the solution design to satisfy business needs and assuring adoptability to future system scalability. What Will You Do In This Role Apply a structured approach to discover, document, and manage business processes, user and stakeholder needs, including opportunity statements, use cases, insights, and requirements. Design, develop, and deploy UiPath RPA solutions to automate Quality Management System processes including document routing, compliance reporting, deviation management, and audit preparation workflows. Build and maintain low-code applications on the Appian platform to support Quality business processes, translating complex QMS requirements into process models, SAIL interfaces, CDTs, records, and reports. Integrate Appian Quality solutions with external systems including Veeva Vault Quality, TrackWise, and enterprise databases via APIs, web services, and other integration methods. Gather insight into user journeys, behavior, motivation, and pain points. Expose unarticulated problems and unmet needs. Document business process, business, and user needs in the form of problem statements to make up the backlog. Facilitate the “how” with the Development team. Gain expertise in the business area. Manage business analysis per agreed priority backlog items in JIRA. Participating in impact assessment activities, reviewing proposed changes and ensuring impact is understood. Deliver product enhancements through agreed backlog process to ensure Quality solutions evolve to meet business needs. Ensure Quality solutions remain compliant as a Validated Solution through verification testing, documentation, and validation efforts. Provide overall leadership, guidance, and management of all aspects of a given solution, including requirements gathering, enhancements delivery plan, and implementation. Initiate projects including defining a scope/charter, identifying stakeholders, and establishing governance. Act as a bridge between Business SMEs, technical teams, and non-technical stakeholders. Communicate delivery status, solution health, risks, and issues to all parties involved and ensure that everyone is aligned and informed. Conduct product status meetings and present updates to stakeholders and senior management. Evaluate delivery performance and implement continuous improvement practices. Understand the technical aspects as well as business process impacts to make informed decisions, provide guidance, and communicate effectively with the development team. This includes having a deep understanding of the QMS business processes, technology stack, architecture, and potential technical challenges. Work closely with the Product Owner to prioritize and refine the product backlog, ensuring that the team focuses on delivering the most valuable features. Identify potential risks and develop mitigation strategies. Proactively address issues that could impact project success. What Should You Have Minimum Level of Education Required Bachelor’s Degree in Computer Science, Engineering, MIS, and Science OR in a related field. The job requires a solid academic background in how Information Technology supports the delivery of business objectives. Preferred Level of Education Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date. 3+ years of experience in technical project management, with a strong understanding of project management methodologies (Agile, Scrum, Waterfall). Understanding Quality Management System Capabilities (Audit/Inspection management, CAPA management, Deviations management, Complaint management). Experience in solution delivery with GMP systems. Experience with architecture, integration, interfaces, portals, and/or analytics. Experience with UiPath RPA development including bot creation, workflow orchestration, exception handling, and deployment in GxP-regulated environments with validation documentation requirements. Proficiency in Appian low-code platform development including process modeling, SAIL interface design, data integration with external databases (SQL, Oracle), and API connectivity for Quality system implementations. Understanding of Systems Development Life Cycle (SDLC), and current Good Manufacturing Practice (cGMP) processes. Knowledge and experience with QMS relevant tools like Veeva Vault Quality and TrackWise. Proven experience leading complex technical projects in a fast-paced environment. Strong technical background with knowledge of software development, systems integration, or related areas. Excellent organizational, leadership, and decision-making skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills to liaise with cross-functional teams. Ability to manage multiple projects simultaneously and adapt to changing priorities Who We Are We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are intellectually curious, join us—and start making your impact today. #HYDIT2025 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Required Skills Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management, Stakeholder Relationship Management, Strategic Planning, System Designs Preferred Skills Job Posting End Date 09/8/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R352363

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e.g., Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master’s degree with 5-9 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: The Future Begins Here: At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement. At Takeda’s ICC we Unite in Diversity: Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team. About the role: The Digital Risk and Compliance, Sr. Analyst is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes. How you will contribute: Develop, initiate, and maintain global policies and procedures for the operation of the compliance program to prevent illegal, unethical, or improper conduct with IT systems and processes Lead and govern the measurement and reporting of risks across the organization, including documentation updates, scoping, assessments, management reporting, and driving remediation of issues Establish, monitor, and report KPIs and Key Risk Indicators Communicate and present key security risks at various levels, including business and technology leaders, to ensure a clear understanding of these risks Provide leadership in maturing the global information security risk management program, including enterprise security reporting and metrics processes to meet the ongoing needs of the business Organize and host internal and third-party audits, providing audit oversight and managing post-audit corrective actions Coordinate with other groups responsible for risk management areas Skills and qualifications: Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc) Working knowledge of manufacturing IT systems like LIMS,MES, TrackWise,etc. Experience working with virtual teams on a global basis In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to Manufacturing IT systems Ability to lead teams in the correct interpretation of regulations Good oral and written communications skills, business acumen with problem solving and analytical skills As an early-career professional, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities. Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions. Key Responsibilities: Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Execute validation tests and compile comprehensive phase reports. Perform risk analysis and mitigation planning for IT systems, laboratory systems, and manufacturing systems. Evaluate and address validation risks associated with system changes, updates, or implementations. Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards. Act as a subject matter expert during validation-related phases of system upgrades or deployments. Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices. Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented. Partner with cross-functional teams to establish validation requirements and ensure project goals align with business and regulatory needs. Provide expertise and guidance on validation processes to project teams and stakeholders. Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices. Serve as a go-to expert for validation-related challenges and initiatives. Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems. Continuously integrate improvements and ensure alignment with regulatory guidelines. Qualifications: 8-10 years of experience in a similar role Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences). Proven experience infrastructure qualification and computer system validation. In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11). Familiarity with cloud qualification practices (nice to have). Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Attention to detail and a commitment to quality. WHAT TAKEDA CAN OFFER YOU: Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people. At Takeda, you take the lead on building and shaping your own career. Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth. Benefits: It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are Competitive Salary + Performance Annual Bonus Flexible work environment, including hybrid working Comprehensive Healthcare Insurance Plans for self, spouse, and children Group Term Life Insurance and Group Accident Insurance programs Employee Assistance Program Broad Variety of learning platforms Diversity, Equity, and Inclusion Programs Reimbursements – Home Internet & Mobile Phone Employee Referral Program Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days) About ICC in Takeda: Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization. Locations: IND - Bengaluru Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time

At Takeda, we are guided by our purpose of creating better health for people and a brighter future for the world. Every corporate function plays a role in making sure we — as a Takeda team — can discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. People join Takeda because they share in our purpose. And they stay because we’re committed to an inclusive, safe and empowering work environment that offers exceptional experiences and opportunities for everyone to pursue their own ambitions. Job ID R0152388 Date posted 07/29/2025 Location Bengaluru, Karnataka I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description The Future Begins Here At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet. Bengaluru, the city, which is India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement. At Takeda’s ICC we Unite in Diversity Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team. About the role: The Digital Risk and Compliance, Sr. Analyst is responsible for managing the global information security risk program across the organization. This individual collaborates with business leaders to understand security and risk issues, oversees risk management and assessment efforts, and develops effective remediation programs. This role supports Takeda's mission by ensuring the security and compliance of IT systems and processes. How you will contribute: Develop, initiate, and maintain global policies and procedures for the operation of the compliance program to prevent illegal, unethical, or improper conduct with IT systems and processes Lead and govern the measurement and reporting of risks across the organization, including documentation updates, scoping, assessments, management reporting, and driving remediation of issues Establish, monitor, and report KPIs and Key Risk Indicators Communicate and present key security risks at various levels, including business and technology leaders, to ensure a clear understanding of these risks Provide leadership in maturing the global information security risk management program, including enterprise security reporting and metrics processes to meet the ongoing needs of the business Organize and host internal and third-party audits, providing audit oversight and managing post-audit corrective actions Coordinate with other groups responsible for risk management areas Skills and qualifications: Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc) Working knowledge of manufacturing IT systems like LIMS,MES, TrackWise,etc. Experience working with virtual teams on a global basis In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to Manufacturing IT systems Ability to lead teams in the correct interpretation of regulations Good oral and written communications skills, business acumen with problem solving and analytical skills As an early-career professional, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities. Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions. Key Responsibilities Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Execute validation tests and compile comprehensive phase reports. Perform risk analysis and mitigation planning for IT systems, laboratory systems, and manufacturing systems. Evaluate and address validation risks associated with system changes, updates, or implementations. Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards. Act as a subject matter expert during validation-related phases of system upgrades or deployments. Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices. Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented. Partner with cross-functional teams to establish validation requirements and ensure project goals align with business and regulatory needs. Provide expertise and guidance on validation processes to project teams and stakeholders. Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices. Serve as a go-to expert for validation-related challenges and initiatives. Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems. Continuously integrate improvements and ensure alignment with regulatory guidelines. Qualifications 8-10 years of experience in a similar role Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences). Proven experience infrastructure qualification and computer system validation. In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11). Familiarity with cloud qualification practices (nice to have). Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Attention to detail and a commitment to quality. WHAT TAKEDA CAN OFFER YOU: Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people. At Takeda, you take the lead on building and shaping your own career. Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth. Benefits: It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are: Competitive Salary + Performance Annual Bonus Flexible work environment, including hybrid working Comprehensive Healthcare Insurance Plans for self, spouse, and children Group Term Life Insurance and Group Accident Insurance programs Employee Assistance Program Broad Variety of learning platforms Diversity, Equity, and Inclusion Programs Reimbursements – Home Internet & Mobile Phone Employee Referral Program Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days) About ICC in Takeda Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day. As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization. #Li-Hybrid Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time

Job Title Regulatory Affairs Excellence Specialist Job Description Job Title : Regulatory Affairs Excellence Specialist Job Responsibilities Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives. Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability. Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience. Executes, manages, and prepares U.S. FDA 510(k) pre-market notification submissions—defining regulatory pathways, compiling technical dossiers, coordinating cross-functional inputs, and driving the process through clearance. Prepares and coordinates FDA Pre-Submissions (Q-Subs) when strategic feedback is required, drafting meeting requests and briefing packages, leading interactions with the Agency, and ensuring follow-up actions are completed. Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented. Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks. Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution. Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations. Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle. Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions. Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards. Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates. Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies. Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards. Minimum required Education: Bachelor's / Master's Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent. Minimum required Experience: Minimum 8-10 years of experience with Bachelor's in areas such as Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. How We Work At Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Company Description Jaidev Pharma Placement is a reputable agency dedicated to providing exceptional human resources services across India, with a focus on the pharmaceutical industry. With over two decades of expertise in Pharmaceutical Sales and more than four years of experience in Hiring, Recruitment, and Training, Jaidev Pharma Placement offers comprehensive HR solutions at highly competitive rates. Our agency excels in strategic planning, business analysis, and revenue generation, ensuring that we meet the unique needs of our clients. We take pride in our ability to create comprehensive improvement strategies and our exceptional people management abilities. Key Responsibilities: Define and drive corporate quality strategy for OSD formulations in alignment with global GMP guidelines Review and approve SOPs, validation protocols/reports, BMRs, BPRs , and other technical documentation Coordinate and support regulatory inspections (USFDA, MHRA, WHO, etc.) and internal audits across manufacturing sites Monitor and analyze deviation, CAPA, OOS/OOT, change controls , and ensure timely resolutions Standardize QA systems and QMS platforms across multiple units Ensure compliance with data integrity principles (ALCOA+) and digital documentation practices Evaluate quality risk assessments, vendor audits , and oversee quality governance practices Drive GMP trainings, audit preparedness , and site-to-corporate quality coordination Provide QA leadership for technology transfer and new product launches in OSD Desired Profile: Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry / Life Sciences) Experience: 8–12 years in QA (corporate/plant level), specifically in OSD manufacturing Strong exposure to regulatory audits , documentation systems, and multisite quality coordination Required Skills: Deep knowledge of GMP, QMS, ICH guidelines, and global compliance standards Proficient in quality tools and documentation platforms (e.g., TrackWise, Veeva Vault ) Excellent written/verbal communication, audit-handling , and leadership skills Team player with a proactive mindset and cross-functional coordination ability Location: Hyderabad Salary: ₹15–20 LPA (Based on experience & current compensation) Joining: Immediate to 45 days preferred

Requisition Id : 1629420 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it’s your career and ‘It’s yours to build’ which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity : Consultant-CHS-Business Consulting Risk-CNS - Risk - Digital Risk - Gurgaon CHS : CHS consists of Consumer Products and Healthcare sectors. Consumer products largely entail, Retail and Agri business. Companies in this sector meet the demands of consumers all around the world, every day; providing everything from agricultural crops to food, clothes, durables and retail experiences. We help clients to capture new sources of profitable growth, rethinking how and where they bring value to consumers, today and into the future. Incumbents need to shift their focus from defending what they have to creating what they need to become. The Health Sciences & Wellness architecture brings together a worldwide network of professionals to build data-centric approaches to customer engagement and improved outcomes. To retain relevancy in today’s digitally focused, data-infused ecosystem, all participants in the sector must rethink their business practices, including capital strategy, partnering and the creation of patient-centric operating models. CNS - Risk - Digital Risk : EY Consulting is building a better working world by transforming businesses through the power of people, technology and innovation. Our client-centric approach focuses on driving long-term value for our clients by solving their most strategic problems. EY Consulting is made up of three sub-service lines: Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting and People Advisory Services. We help our clients in identifying and managing the interplay between upside and downside risk in order to make the long-term decisions to prevent risk and impact on their organization's ability to meet its future business strategy and objectives. The 3 key fields of play are : Enterprise Risk - helps clients identify and address key risk areas, while building the agility to respond quickly. The areas of focus include Enterprise risk and resilience, Internal audit, Compliance and Internal controls Technology Risk - helps clients to achieve sustainable growth by supporting their efforts to protect their business performance and by providing trusted communications on internal control and regulatory compliance to investors, management, regulators, customers and other stakeholders. EY teams accomplish this by assessing the technology risks that are introduced to businesses. Financial Services Risk - helps clients in the financial sector to identify, manage and monitor the risks in their business. It is done through a transformative and agile approach including process and procedures, risk, data modeling and analytics, reporting to stakeholders and third parties, business requirements (for software selection and IT implementation), analysis of assets and liabilities, and capital and liquidity management. Your key responsibilities Technical Excellence Expert in setting IT integration landscape setup from ground ZERO with partners. ? Developed more than 1000+ interfaces which includes End to end integration with CMO’s , 3PL’s , Serialization tools using SAP ATTP , SAP PI/PO , LIMS , Trackwise Ivalua , SAP ICH , Tracelink etc , Packaging line applications , Optel Vision , ACG etc. ? Experienced in EDI capability setup for Sales and Operation Planning , PTP, OTC, 3PL etc. ? Integration with iOT applications over Azure/AWS for measuring the efficiencies on real time basis for critical decision-making. ? Experience in setting up SAAS applications like Salesforce ,iValua, BIZOM , WareIQ , SAP ICH , Oracle HRMS , SAP Concur , Happay , Planning applications like GAINS etc ? Experience in Artwork application like Goose , Mass mailer applications, SharePoint etc ? Implemented GST/e-Way Bill and e-Invoicing solution ? Integration with various banks for payment processes and with Oracle FCCS i.e Hyperion for consolidation ? Sales automation via implementing solutions like Field force automation , CRM implementation and integration with ERP , BIZOM , Ware IQ etc. ? Automation of multiple operational processes via UiPath .Saving of 8-10 man hours every day . ? SAP Carve out, Rollout , SAP Upgrade projects etc. Skills and attributes To qualify for the role you must have Qualification M.C.A ? Trained and Certified in SAP PI/PO , SAP application. ? Certified in TOGAF , ITIL V3 , Solace Experience Santosh is a seasoned Integration expert with nearly 20 years of experience in the Life Sciences sector. He has developed various complex integration in pharmaceuticals domain for applications like – Serialization(SAP ATTP/SAP ICH/ Optel),LIMS(Labvantage), QMS/WMS(SAP , 3rd party) external databases, APIs, and analytics tools. His expertise in leveraging Web Services enables seamless data flow and compliance across systems, supporting efficient operations and informed decision-making in highly regulated environments What we look for People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful and able to sustain postivie energy, while being adaptable and creative in their approach. What we offer With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, we are investing more time, technology and money, than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills and opportunities. EY is equally committed to being an inclusive employer and we strive to achieve the right balance for our people - enabling us to deliver excellent client service whilst allowing our people to build their career as well as focus on their wellbeing. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now.

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e.g., Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master’s degree with 8-13 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

QA Technical Specialist The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e.g., Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master’s degree with 8-13 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

What You Will Do- Understanding of end-to-end complaint lifecycle Collect data from multiple sources such as Trackwise and translate the data into meaningful Power BI Dashboards and visualizations Author and peer review Post market plans/reports on JR products sold worldwide. Provide technical expertise in data analysis, data preparation and performance monitoring Build, manage and maintain reports, dashboards and visualizations as needed Communicate key findings to business partners and leadership throughout the organization Help develop automated solutions for dashboard and report generation Generate and analyze metrics and make recommendations as required Generate data for Competent Authorities (FDA, BSI and other regulatory bodies). Required- What you need- Experience on Post Market Surveillance as per US FDA & EU MDR; Quality Management (ISO 13485 or 21 CFR 820) and experience with TrackWise and Microsoft Project Minimum 4-7 years of experience in Medical Device domain Understanding on Medical Device Risk Management Strong Analytical and Statistical Skills (proficient in Advance Excel, Power BI. Tableu, Minitab) Preferred- Ability to influence and motivate the cross functional team. Project management experience and experience to lead & achieve global process improvement efforts. Experience of working with multiple teams and collaborating across geographically spread multi-functional teams Strong interpersonal skills & communications skills Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

What will you do: Basic knowledge and understanding of complaint handling process as required by regulatory agencies. Provide updates within Trackwise on status of product field action executions and event detail information. Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams. May support international and domestic complaint entry. Work with internal supporting teams on quality of data coming into post market May monitor, create, and assign regulatory communications to quality specialists for resolution. What you will need: Basic Qualifications: Minimum 2 to 5 years relevant experience required Basic knowledge and understanding of complaint handling and product field action process as required by regulatory agencies Basic knowledge on Trackwise Basic understanding of how to comply with constantly changing regulatory procedures preferred Preferred Qualifications: Must possess strong interpersonal skills including written and oral communication. Must be able to bring tasks through to completion with minimal supervision. Must have the ability to prioritize work and keep detailed and confidential records. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Job Description Major Accountability: Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. Support implementing service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services, report deliverables. Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital. Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables. Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise etc.) to ensure appropriate execution of service deliverables. Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM, etc.) and perform follow-up actions, if required. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape!

Requisition Id : 1629420 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it’s your career and ‘It’s yours to build’ which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity : Consultant-CHS-Business Consulting Risk-CNS - Risk - Digital Risk - Gurgaon CHS : CHS consists of Consumer Products and Healthcare sectors. Consumer products largely entail, Retail and Agri business. Companies in this sector meet the demands of consumers all around the world, every day; providing everything from agricultural crops to food, clothes, durables and retail experiences. We help clients to capture new sources of profitable growth, rethinking how and where they bring value to consumers, today and into the future. Incumbents need to shift their focus from defending what they have to creating what they need to become. The Health Sciences & Wellness architecture brings together a worldwide network of professionals to build data-centric approaches to customer engagement and improved outcomes. To retain relevancy in today’s digitally focused, data-infused ecosystem, all participants in the sector must rethink their business practices, including capital strategy, partnering and the creation of patient-centric operating models. CNS - Risk - Digital Risk : EY Consulting is building a better working world by transforming businesses through the power of people, technology and innovation. Our client-centric approach focuses on driving long-term value for our clients by solving their most strategic problems. EY Consulting is made up of three sub-service lines: Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting and People Advisory Services. We help our clients in identifying and managing the interplay between upside and downside risk in order to make the long-term decisions to prevent risk and impact on their organization's ability to meet its future business strategy and objectives. The 3 key fields of play are : Enterprise Risk - helps clients identify and address key risk areas, while building the agility to respond quickly. The areas of focus include Enterprise risk and resilience, Internal audit, Compliance and Internal controls Technology Risk - helps clients to achieve sustainable growth by supporting their efforts to protect their business performance and by providing trusted communications on internal control and regulatory compliance to investors, management, regulators, customers and other stakeholders. EY teams accomplish this by assessing the technology risks that are introduced to businesses. Financial Services Risk - helps clients in the financial sector to identify, manage and monitor the risks in their business. It is done through a transformative and agile approach including process and procedures, risk, data modeling and analytics, reporting to stakeholders and third parties, business requirements (for software selection and IT implementation), analysis of assets and liabilities, and capital and liquidity management. Your key responsibilities Technical Excellence Expert in setting IT integration landscape setup from ground ZERO with partners. Developed more than 1000+ interfaces which includes End to end integration with CMO’s , 3PL’s , Serialization tools using SAP ATTP , SAP PI/PO , LIMS , Trackwise Ivalua , SAP ICH , Tracelink etc , Packaging line applications , Optel Vision , ACG etc. Experienced in EDI capability setup for Sales and Operation Planning , PTP, OTC, 3PL etc. Integration with iOT applications over Azure/AWS for measuring the efficiencies on real time basis for critical decision-making. Experience in setting up SAAS applications like Salesforce ,iValua, BIZOM , WareIQ , SAP ICH , Oracle HRMS , SAP Concur , Happay , Planning applications like GAINS etc Experience in Artwork application like Goose , Mass mailer applications, SharePoint etc Implemented GST/e-Way Bill and e-Invoicing solution Integration with various banks for payment processes and with Oracle FCCS i.e Hyperion for consolidation Sales automation via implementing solutions like Field force automation , CRM implementation and integration with ERP , BIZOM , Ware IQ etc. Automation of multiple operational processes via UiPath .Saving of 8-10 man hours every day . SAP Carve out, Rollout , SAP Upgrade projects etc. Skills and attributes To qualify for the role you must have Qualification M.C.A Trained and Certified in SAP PI/PO , SAP application. Certified in TOGAF , ITIL V3 , Solace Experience Santosh is a seasoned Integration expert with nearly 20 years of experience in the Life Sciences sector. He has developed various complex integration in pharmaceuticals domain for applications like – Serialization(SAP ATTP/SAP ICH/ Optel),LIMS(Labvantage), QMS/WMS(SAP , 3rd party) external databases, APIs, and analytics tools. His expertise in leveraging Web Services enables seamless data flow and compliance across systems, supporting efficient operations and informed decision-making in highly regulated environments What we look for People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful and able to sustain postivie energy, while being adaptable and creative in their approach. What we offer With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, we are investing more time, technology and money, than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills and opportunities. EY is equally committed to being an inclusive employer and we strive to achieve the right balance for our people - enabling us to deliver excellent client service whilst allowing our people to build their career as well as focus on their wellbeing. If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible. Join us in building a better working world. Apply now.

We are seeking an experienced Computer System Validation (CSV) Specialist to lead and support the validation of GxP-compliant systems used in manufacturing, laboratories, and quality assurance functions. The ideal candidate will possess strong domain knowledge in pharma operations, validation methodologies, and regulatory compliance, along with hands-on experience in validating systems like TrackWise, SAP, SCADA , and MES . Key Responsibilities: Develop and execute CSV lifecycle documentation : URS, Risk Assessment, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports. Ensure compliance with 21 CFR Part 11 , Annex 11 , GAMP 5 , and GxP guidelines. Manage validation of GxP-critical systems including LIMS, QMS, ERP, PLC/SCADA , and electronic batch record (EBR) platforms. Collaborate with cross-functional teams (QA, IT, Manufacturing, Lab) for smooth implementation and validation of computerized systems. Review and approve vendor-supplied documentation and software qualification deliverables. Participate in audits and inspections; ensure readiness of CSV documentation and responses to regulatory bodies. Maintain Change Control and Periodic Review activities for validated systems. Provide training to stakeholders on system validation procedures and compliance expectations. Required Qualifications: B.Pharm from a recognized university (M.Pharm or additional certifications in CSV is a plus). 5–8 years of relevant experience in Computer System Validation in a regulated pharmaceutical or life sciences environment. Strong working knowledge of LIMS , TrackWise , SAP , MES , or other pharma-grade software systems. Familiarity with data integrity principles , GAMP 5 guidelines, and risk-based validation approaches (CSA exposure is a plus). Good documentation practices and ability to work across cross-functional teams. Key Skills & Competencies: Expertise in CSV lifecycle and compliance frameworks Strong understanding of pharma shop floor and laboratory processes Risk assessment & validation planning Cross-functional communication and stakeholder management Audit preparedness and regulatory interaction experience

newmark is looking for Analyst 1 - Gerald Eve to join our dynamic team and embark on a rewarding career journeyCollect, analyze, and interpret data from various sources to support business decisions and strategy development.Prepare detailed reports, dashboards, and visualizations that highlight trends, patterns, and actionable insights.Collaborate with cross-functional teams to understand data requirements and deliver accurate analytical solutions.Use statistical methods and data modeling techniques to solve business problems and improve processes.Validate data integrity and ensure accuracy in all analyses and reports.Monitor key performance indicators (KPIs) and provide regular updates to management with recommendations.

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities Lead the engagement efforts at different stages from Problem definition to diagnosis to solution design, development & deployment, contribute to unit level & Organizational initiatives. Design, Build & Optimize End to End SAP Quality Management Processes for customers enterprise. Engagement Life cycle Management Client Opportunity Identification and Proposal Development Client Relationship Management Talent Management Marketing and branding using Thought Leadership Deal Influencing, Negotiation and Closure IP Creation and Management Knowledge Management Additional Responsibilities: SAP QM (Quality Management) with Pharma & Process Industry experience. The candidate is expected to be a senior Functional Architect for SAP Programs and will anchor the engagement effort for assignments, all the way from business process consulting and problem definition to solution design, development, and deployment for S/4HANA Quality Management. You will lead business transformation programs helping clients mitigate Digitization related challenges. You will be pivotal to problem definition and discovery of the overall solution and guide teams on project processes, deliverables. You will have the opportunity to shape value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape. Domain experience in Quality Management with S/4HANA certification (preferred). Experience in Deal Pricing & Transformation Deal Estimations, Ability to work with different tools like, Solman, Doc Nav, Sharepoint, Mercury QC etc. Sufficient ABAP, Fiori, Technical know-how to co-ordinate better with technical teams. Should have experience of Change Management, Task Planning, Project Reporting, Resource Management, Process Improvement, Supervising. Technical and Professional Requirements: 15+ years of experience in SAP transformation, development, and AMS projects with at least 3 End-to-End implementation projects Business Process Knowledge of topics viz. Quality Planning, Quality inspection, Quality Control, Quality certificates, Quality Notifications, Stability Studies, Batch Management etc. Experience of integrating SAP QM with External system 3PLs like MES, Trackwise, LIMS, Labware, Lab Vantage etc., and with other SAP modules, GXP and SOX requirements Experience as Solution Architect in the multiple programs of global scale Experience in Business Blue Printing, Design, Prototyping, Functional Analysis, Configuration, Gap Analysis, Conversion, Migration, Testing, Training, Cutover, Go-Live and Post Go-live Support activities, driving Business process workshops and Fit/GAP analysis Deep Knowledge and expertise in Quality Management BPML Good experience in Data migration process and ETL Tools Preferred Skills: Technology-SAP Functional-SAP QM

Who We Are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with. The opportunity The Director, Regulatory Affairs – Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U.S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key liaison with the FDA, internal stakeholders, and external partners. How You’ll Spend Your Day Define and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams. Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc. Establish and maintain strong relationships with FDA project managers. Monitor and interpret evolving FDA regulations, guidances, and enforcement trends; proactively adapt strategies and internal processes. Develop and implement regulatory policies, SOPs, and training programs to ensure consistent and compliant practices across the organization. Lead, mentor, and develop a high-performing regulatory team, fostering a culture of accountability, innovation, and continuous learning. Represent Regulatory Affairs in global governance forums, strategic planning sessions, divestment assistance and support of internal initiatives. Initiate/manage notices of commercial launch and product obsoletion, as well as updates to the Orange Book. Your Experience And Qualifications Pharm D or M. Pharma in a scientific discipline. Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products. Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains. Deep expertise and applied knowledge of FDA regulations (21 CFR 314.70), ICH guidelines, and eCTD submission standards. Experience with regulatory systems (e.g., Veeva, TrackWise) and electronic document management systems (e.g. Wisdom, Glorya, Livelink, Knowledgetree). Demonstrated success in leading regulatory strategy, agency interactions, and lifecycle management for ANDAs/NDAs. Strong business acumen and ability to align regulatory strategies with commercial and operational objectives, while maintaining regulatory compliance. Demonstrates a basic understanding of pharmaceutical drug development. Demonstrated/proven track record of FDA interactions, as well as negotiation and influencing skills. Demonstrates excellent verbal and written communication skills. Experience working in a matrixed, multinational environment, as well as with third parties. Experience with regulatory intelligence, policy shaping, and industry advocacy is a plus. Lean Six Sigma certification, or other accreditation related to improving business processes is a plus. Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. 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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.