292 Trackwise Jobs - Page 11

Trending Job Description This role supports Quality Management System (QMS) activities including tracking and reviewing CRFs, CAPAs, deviations, and SOPs across multiple sites. Responsibilities include documentation control, data analysis, digital transition support, and coordination with site teams to ensure compliance with cGMP standards. The position also involves audit support, workflow optimization, and cross-functional collaboration to drive timely closure of quality events Responsibilities Track and follow up on pending TrackWise CRFs and CAPAs. Perform effectiveness checks for closed CAPAs and CRFs. Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs). Monitor and track SOP periodic reviews across sites. Support SOP updates, including formatting checks and revision history verification. Facilitate the creation and routing of CRFs for SOP revisions. Assist in the transition from physical to electronic forms (Leucine project). Support the review of manufacturing documentation (e.g., shipping/receiving logs, PM records). Collaborate on defining and improving document workflows and review processes. Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed. Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance. Collaborate with site teams to resolve gaps identified during QMS event review and documentation. Engage with customers and site teams to ensure timely closure of critical QMS events. Coordinate site review activities and ensure workflow efficiency. Route documents through the ENSUR application or other platforms across Piramal plants. Participate in customer audits and regulatory inspections, supporting site teams as needed. Lead or contribute to additional assignments as directed by the Head of Department (HOD). Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8772 Posting Date 06/03/2025, 08:44 AM Apply Before 06/30/2025, 08:43 AM Degree Level Bachelor's Degree Job Schedule Full time Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN Show more Show less

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

Hands-on experience on testing tools like HP ALM, Kneat and SNOW - Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of understanding - OT Security will be a plus. - Standalone Systems Qualifications - PAS/DCS Integrated with Manufacturing Equipment qualification. Key components of the responsibilities are as mentioned below but not limited to:  6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.  Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.  Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.  Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.  Stakeholder management and good executor with required communication.  Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test Management & Compliance  Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.  Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality suite is a single authoritative source, enabling greater visibility and control. Vault Quality enables organizations to modernize quality management, assuring quality while driving compliance and operational innovation. We are looking for Consultants with Life Sciences experience and a passion for helping customers optimize their quality data and document management operations in the cloud. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Support Functional Analysts in workshops and be part of customer discussions of the Vault Quality suite (Vault QMS, Vault QualityDocs, Vault Training) Quality/Content management solution design, prototyping, configuration, and documentation Solution and configuration of Veeva Vault Quality Suite per customer requirements, including workflows, document types, security, fields, page layouts, reports, dashboards, formatted output reports, and notifications Leveraging enablement of out-of-the-box or best practices configuration approach to solution strategy Assessing the impact of change on the current configuration and working with key stakeholders to make informed decisions in a timely manner Represent Professional Services across multiple engagements and workstreams (e.g., solution design and configuration, data migration, systems integration, etc.) Ensure customer success from the beginning to the end of the engagement life cycle Requirements 4+ years of experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Bachelor's Degree in Life science, computer science, or related degree Solid analytical and great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Ability to act with speed to understand business requirements and willingness to "roll up your sleeves" to design and implement a solution Exposure to life sciences compliance and computer systems validation requirements Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality process and content management, life sciences compliance, and/or computer systems validation Proven track record leading high-impact global system implementation programs as a consultant, business, or IT lead, and/or business sponsor Direct experience with systems, such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems SaaS/Cloud experience Knowledge of Quality operations within the Life Sciences, Pharmaceutical, Biotech industry, and/or equivalent. Perks & Benefits Flexible PTO Health & wellness programs Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have Responsibilities The Regulatory Lead role is responsible for managing regulatory operations including initial submissions and life cycle management of products, ensuring regulatory compliance in all marketed regions. This includes: Planning and execution of new product registrations, line extensions, new indications, license renewals, variations management, and label updates throughout the life cycle of a marketed product ensuring compliance with local regulations and quality system requirements. Preparing, reviewing, and submitting regulatory dossiers for marketing authorization (MA) applications, ensuring timely and high-quality submissions in compliance with Health Authority regulations including but not limited to US, CA, EU, LATAM, APAC, GCC, and CIS countries. Managing post-approval activities, preparing and submitting applications for registration and import licenses, renewals, variations and ensuring compliance and timely renewals of regulatory commitments, while working with the client, and their local affiliates as applicable. Building and leading an excellence-focused team ensuring key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Facilitating and cultivating relationships with local Regulatory Agencies/affiliates and Health Authorities to achieve successful outcomes and strategic alignment for submissions and schedules in each country. Ensuring Regulatory submissions and subsequent HA communication/responses within planned timelines. Voicing affiliate perspectives and needs to global and regional regulatory contacts. Maintaining regulatory tools in alignment with defined compliance metrics. Staying aware of current regulations and anticipating the implications and opportunities of changes in the regulatory environment. Communicating changes to appropriate management and cross-functional experts and implementing them locally. Addressing complex regulatory and business challenges, collaborating across functions and regions to drive favorable outcomes and acting as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems. Assessing change control issued by quality or regulatory departments, evaluating regulatory impact, and developing submission strategies. Ensuring accurate documentation and management of regulatory activities and data, maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards. Leading meetings with clients to discuss proposals, project status, and general business development activities. Developing and implementing long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency. Requirements: BPharm, MPharm, Pharm D, or MSc. 8-10 years in Regulatory Affairs and Submissions Management. Experience with life-cycle management activities (e.g. Europe, USA, International would be an asset). In-depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (EU - CP, MRP, DCP, National etc.) and LCM strategies. Familiarity with Veeva RIMS, TrackWise, and other RIMS systems. Strong project management and documentation skills, proactive communication approach. Great customer service skills, able to work well and manage a team. Advanced skills in Microsoft Office and Adobe Professional. Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title – Research Associate III (Testing Coordinator) Location – Whitefield, Bangalore Shift – General This position is responsible for The Testing Coordinator will utilize his/her scientific knowledge to own operational excellence and continuous improvement; This role involves streamline processes; coordinate business, management, and technical SMEs; identify risks; devise solutions, all to support the establishment of Operational excellence. Essential Duties And Responsibilities Provide business and execution leadership for multiple analytical and stability-related projects and holding accountability for testing schedules, risks, and interacts with all functions and levels of management ensuring effective communications. Lead internal initiatives that enhance operational excellence. Interact with platform core team leaders and other key business stakeholders to be able to proactively anticipate business needs. Process inputs from Global Analytical, Stability Functional Leader and Analytical leads and Stability SMEs to determine schedules and forecast resource allocations to projects. Ensuring the availability of all prerequisites for scheduled laboratory analytical and stability testing. Master the planning of activities for testing and ensure on-time completion of all testing activities. Effectively coordinate testing with global teams and CROs as applicable to meet the KPIs on time. Interact with other testing groups (Particle, Sterility/BET, etc.) to determine schedules and alignment with business needs/function commitments. Ensure the maintenance of laboratory compliance as per regulatory requirements. Ensure import licenses are in place and manage laboratory samples inventory. Coordinate with procurement and technical teams for on-time procurement of chemicals and resolution of analytical instrument problems. Coordinate with external and internal sample shipment personnel’s for receiving testing samples on time. Participate in handling of laboratory investigations that correspond to atypical or out-of-specification/out-of-trend test results and other nonconformance records and leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles and propose appropriate corrective and Preventive root causes. Author/Follow SOPs of relevant procedures. Qualifications Proven experience in stability testing, analytical method validation and transfers, laboratory management, or a similar role. Strong leadership and project management skills. Excellent communication and interpersonal skills. In-depth knowledge of relevant QSRs, GxP, and other regulatory requirements. Handling of software like Trackwise. Proficiency in resource planning and inventory management. Critical thinking and problem-solving skills. Ability to work effectively in cross-functional and global teams. Proactive and able to anticipate business needs and challenges. Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) Education: Master’s in chemistry or Pharmaceuticals, with 6 to 10 years of experience. Education And/or Experience Bachelor’s degree with 8-14 years’ or Master’s degree with 5 to 10 years' of experience in relevant scientific discipline (Analytical chemistry/Pharmaceutical chemistry). Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Work as a team to support Process Solutions organization of Company’s LS to achieve the goal. Process service complaints in Trackwise and ERP. Hands on experience in ERP system SAP, Oracle and CRM tool SFDC. Knowledge of order management process and the concept of creating debit & credit. Partner with team to deliver quality services, enhance operational efficiencies. Process customer documentation requests and Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Create orders in ERP/other tools for credit, debit, investigation and return and establish the strong follow ups with key partners to close the requests in SFDC. Coordinating with Customer master data team to update customer masters. Process on discrepancy area database request and quality task request in ERP system. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Who You Are Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP. Experience in Order Management / Service Complaints with 1-2 experience is preferred. Should possess basic knowledge of SFDC Functional Knowledge and ERP (SAP& Oracle) User Knowledge. Hands-on experience on ERP’s like SAP, SFDC. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less

India - Hyderabad JOB ID: R-214289 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Apr. 29, 2025 CATEGORY: Quality Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role The Migration Consultant will be an important member of the Veeva Systems Professional Services group, implementing migration solutions for our global project teams, which implement Veeva Vault R&D applications and Vault Platform cloud solutions for companies in the life sciences industry. The Migration Consultant will work on customer migration implementations using the best practices and expertise with data and document content migration, Vault API, Vault migration tools, and Vault Platform best practices. Migration Consultant is a customer advocate working closely with other Veeva teams (Services, Product) to ensure customer success today and in the future. This is a remote, full-time, permanent role with Veeva. What You'll Do Contribute to Vault R&D migration implementation, including the migration of document content and object data from legacy systems to Vault Work on Migration Projects from A to Z and support customer Validation exercise Work with Data Migration Leads and Architects on migration activities and best practices Contribute to our knowledge base to build a migration program Develop internal and external tools to help our customers and consultants Requirements 3+ years of direct experience with Veeva Development Cloud applications 3+ years of customer-facing technical consulting experience 3+ years of working experience in implementation or data migration or integration consulting with enterprise software systems (Documentum, Trackwise, Sharepoint, SAP, Salesforce.com, Siebel, Oracle, Argus, ArisGlobal, etc.) Good skills with SQL and databases, REST APIs Strong presentation skills, verbal & written communication skills Experience working in large complex project teams and global clients Strong interpersonal skills Nice to Have Experience with the Pharmaceutical and Life sciences industry Experience with Clinical, Quality, Regulatory, or Safety business processes Background and experience in data migrations or integrations Experience working with ETL tools/products, Python, Java Background with GxP and software validation regulations Background with the migration verification process Perks & Benefits Opportunity for rapid progression in a high-growth business Health & wellness programs Flexible vacation policies 1% charitable giving program Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

Job Summary We are seeking a Product Analyst with 2 to 5 years of experience to join our team in a hybrid work model. The ideal candidate will have expertise in TW-Basic Config and Trackwise On-prem with a preference for experience in the Medical Devices domain. This role involves analyzing product performance and contributing to product development strategies ensuring alignment with company goals. Responsibilities Analyze product performance data to identify trends and insights that drive product improvements. Collaborate with cross-functional teams to gather and document product requirements. Provide technical expertise in TW-Basic Config and Trackwise On-prem to support product development. Develop and maintain product documentation to ensure clarity and consistency. Conduct market research to understand customer needs and competitive landscape. Assist in the creation of product roadmaps and strategies to align with business objectives. Monitor product lifecycle and recommend enhancements based on user feedback. Support the implementation of product changes and updates to improve user experience. Communicate effectively with stakeholders to ensure alignment on product goals and priorities. Utilize data analytics tools to measure product success and inform decision-making. Ensure compliance with industry standards and regulations particularly in the Medical Devices domain. Participate in product testing and quality assurance to ensure high standards are met. Contribute to the continuous improvement of product management processes. Qualifications Possess strong analytical skills with the ability to interpret complex data sets. Demonstrate proficiency in TW-Basic Config and Trackwise On-prem. Exhibit excellent communication skills in English both written and spoken. Show a keen understanding of the Medical Devices industry is a plus. Display the ability to work collaboratively in a hybrid work environment. Have a proactive approach to problem-solving and decision-making. Maintain a customer-focused mindset to enhance product offerings. Show more Show less

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. 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 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, 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. Show more Show less

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. 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 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, 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. Show more Show less

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. 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 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, 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. Show more Show less

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. 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 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, 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. Show more Show less

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. 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 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, 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. Show more Show less

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. 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 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, 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. Show more Show less

Be the First to Apply Job Description Business: PPL Digwal Department: TSD Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - TSD Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 6-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Initiation of change controls Prepare the new BMRs, BPRs & ECRs as per requirement. Revision of existing BMRs, BPRs and ECRs as per requirement. Monitor & close the CAPAs. To plan the daily activities in the concerned production blocks. Close the pre- action & post- actions related to change controls in trackwise. Initiation and of review of deviation and investigation reports. Review the executed BMRs, BPRs, ECRs etc. Indenting & receiving of new / executed BMRs, BPRs, ECRs etc. Provide the response to the internal / external parties comments & update the documents. Follow the safety precautions. Maintain discipline at the work place. Ensure effective implementation of the cGMP compliance and quality management system in the plant. Follow the cGMP system and provide the training on change documents, SOP, CAPAs related to investigations, deviation etc. as per requirement. Any other responsibilities assigned from time to time as per requirement. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) Job Info Job Identification 5344 Posting Date 05/28/2025, 09:16 AM Apply Before 05/30/2025, 09:16 AM Degree Level Technical Diploma/A Level Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less

Title: Downstream Process Development Date: 27 May 2025 Job Location: Bangalore Pay Grade Year of Experience: Job Description Designation: Senior Research Associate Job Location: Bangalore Reporting to: Principal Investigator Job Grade: 9-II The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. Key Result Areas Role-specific Support the DSP team with basic activities such as preparation of buffers and reagents. Designing of purification processes for novel fusion antibodies; antibody fragments and other new formats. Planning and execution of experiments associated with process development, late phase process optimization, process characterization activities. Interaction with relevant cross functional team for smooth functioning of the daily activities. Regular documentation of experiments contemporaneously in electronic lab notebook. Compilation of experimental data for further evaluation. Authoring technical reports and communicating the key findings. Participating in the weekly team meetings. Actively involve in scale-up and technology transfer to manufacturing. Troubleshoot recipes in purification systems -AKTA Pure, AKTA pilot & TFF System and develop long-term solutions for the betterment of purification platform. Enable the team in procurement of raw materials and consumables and in lab maintenance and remove any obstacle in maintaining lab inventories. Author, review protocols, reports, scale up & scale down studies, tech transfer documents, deviation & OOT reports and executed BMRs. Actively participate in quality related investigations and propose effective corrective and preventive actions. Ensure compliance in issuance of lab notebooks and archival of records such as logbooks, lab notebooks, protocols, reports, documents in electronic management system. Well versed with Track wise or similar QMS systems. Education And Experience Education Master’s degree in Life Science, Chemical Engineering, Biotechnology, or related field. Industry Experience Minimum 2-4 years of relevant practical experience in downstream process development specifically with monoclonal antibody purification Other Competencies Required For The Role Basic knowledge of downstream purification principles is essential for this role. Proficient in handling of AKTA Systems or equivalent. Experience in scale-up and tech transfer is preferable Experience in using electronic lab notebook, Electronic Database Management System (EDMS), TrackWise is preferable not mandatory. 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. Pls visit us at https://syngeneintl.com/ to know more about us and what we do. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality platform will truly change how the industry manages Quality, and we want you on our team! Veeva Systems is looking for a Project Manager who has a deep customer focus and a passion for helping customers transform the way they manage their Quality data and content within our product. This is an expert-level role that requires strong Quality domain experience, customer-focused project management, and problem-solving skills as you lead and manage large-scale global enterprise cloud software projects for Veeva. Ability to drive governance at all levels and lead a consulting team in an enterprise implementation project. We are looking for individuals with exceptional abilities in the delivery of large cloud transformation programs across the enterprise and client relationship management, and leadership skills to manage a team to grow and thrive in an environment with professional agility. If you excel in building productive relationships, aligning strategies, and excelling in a dynamic environment, then this could be an excellent match for you. Candidates must be based in Mumbai, India, or willing to relocate. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Collaborate with the client’s leadership and other Project Managers to establish and execute a sound project management methodology for delivering Services related to the implementation of the Vault Quality suite Provide oversight for Services projects and deliver agreed services on time and with high customer satisfaction Establish close, collaborative relationships with customer stakeholders to understand and act on customer needs Drive governance and demonstrate leadership by working across customer and internal teams to support all phases and workstreams within the implementation of the Vault Quality suite of applications Manage day-to-day project activities and project administration Enable your project team to focus on solution design, prototyping, configuration, training, and documentation Mentor project team members in the Services organization and identify growth opportunities Proactively manage risk, anticipate potential problems, and identify mitigation strategies Be transparent in all communications and reflective in conducting post-project assessments — identify learnings that will help improve the overall process Establish and provide regular reporting on project status, key metrics, and deliverables, and customize to address key stakeholder groups Requirements 10+ years of direct experience leading teams working with GXP Quality software solutions across QMS, DMS, LMS, LIMS, Validation Lifecycle Management, and/or delivering project management for related services in a Life sciences organization Experience in reporting to senior/executive-level stakeholders and technology teams with superior communication skills Exceptional project management skills with the ability to prioritize and manage multiple projects in a cross-functional environment that values speed Experience working with different LMS platforms such as SuccessFactors, Compliance Wire, and Vault Training The position requires a level of confidence to hold the line with customers and internal teams and be an advocate for the project Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results Ability to travel up to 20% Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality, Content Management, life sciences GxP training compliance, as well as QC LIMS and/or Validation Experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Direct experience with systems such as Veeva Vault Quality, Honeywell Sparta TrackWise, OpenText, Documentum D2, Biovia QUMAS, UL Compliance Wire, and SAP Success Factors Consulting experience Life Science, computer science, biochemical, and mechanical engineering or related degree SaaS/Cloud experience Perks & Benefits Allocations for continuous learning & development Health & wellness programs Flexible PTO Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

Company Description Epitome Components Ltd. is a leading PCB manufacturer in India with advanced infrastructure and a huge production capacity of 100,000 sqm/month. The company has a satisfied customer base both in India and abroad, including leading Indian and MNCs such as Videocon, LG, Nokia, and others. Epitome has a joint venture with UK-based company "Trackwise Designs Ltd." for manufacturing RF Antenna PCBs for various high-end applications. Role Description This is a full-time on-site role as a Production Planning Engineer located in Ahmednagar. The Planning Engineer will be responsible for day-to-day tasks related to planning, analytical skills, production planning, communication, and project control within the manufacturing environment 2 to 5 Years Experience. Qualifications Planning and Production Planning skills Analytical Skills Strong communication skills Project Control capabilities Experience in the manufacturing industry is a plus Bachelor's degree in Engineering or related field Show more Show less

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: 2+ 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. Show more Show less

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: Are you a passionate, dedicated & detailed oriented professional, then the opportunity is for you to join our Quality Assurance Team at Zydus Takeda Healthcare Private Limited, Turbhe, Navi Mumbai - A joint venture of Zydus Lifesciences and Takeda Pharmaceuticals.: For more Company Details logon to -: https //www.takeda.com/en-in/who-we-are/about-zydus-takeda/: Job Title: Senior Executive / Executive - Quality Assurance Location: Navi Mumbai About the role: The role will be responsible for In-Process Quality Assurance (IPQA) responsible for monitoring and controlling the quality of products during the production process. This role ensures that manufacturing processes comply with regulatory standards and company quality policies to maintain the highest level of product integrity and safety. How you will contribute : Perform real-time monitoring of production processes to ensure adherence to quality standards. Conduct routine inspections and in-process checks to verify compliance with specifications and protocols. Collaborate with production and quality control teams to address any quality issues promptly. Identify deviations - OOS, OOT and non-conformances, and implement corrective and preventive actions (CAPA). Ensure proper documentation of all quality-related activities and maintain accurate records. Review Batch Manufacturing Records (BMRs) and Analytical data reviews. Review Validations and Qualifications activities & documents. Participate in internal audits and inspections to ensure continuous compliance with GMP, SOPs, and other regulatory requirements. Provide training and support to production staff on quality procedures and best practices. Work closely with the quality assurance team to develop and review quality-related documents, including standard operating procedures (SOPs) and batch records. Education: Post Graduate / Graduate in Science or Pharmacy from reputed institute. Hands on experience and knowledge of Quality Management System. Strong understanding of GMP, FDA regulations, and ICH, cGMP industry standards. Experience: Minimum 6 to 8 years of experience in pharma manufacturing plant preferably API Manufacturing Plant with experience of IPQA in rotational shifts. Proficiency in using quality management software and tools like Trackwise, SAP, etc. Desired Skills : Excellent observational and attention-to-detail skills. Ability to work effectively in a team-oriented, fast-paced environment. Strong problem-solving and decision-making capabilities. Good documentation and record-keeping skills. Continuous improvement mindset and ability to handle multiple tasks efficiently Locations: IND - Navi Mumbai Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Show more Show less

SAP Master Data Expert - 6 months - Contract - Full time - Remote with AdHoc Travel We are seeking a meticulous and collaborative SAP Master Data Expert with functional business experience in SCM and MM to support enterprise-wide data transformation initiatives within the pharmaceutical sector. This role plays a critical part in ensuring the integrity, compliance, and readiness of master data—particularly in regulated domains such as manufacturing, quality, regulatory, and clinical systems. You will work closely with IT, regulatory affairs, quality assurance, and business stakeholders to ensure seamless data migration from legacy systems to validated platforms. Key Responsibilities Data Preparation & Governance Collaborate with IT and country-level Business Data Owners to identify in-scope data objects, including product, material, batch, and regulatory data. Maintain and govern master data lists for assigned objects, ensuring alignment with GxP and data integrity standards. Support the development of value mappings and data transformation rules in collaboration with technical teams. Provide domain-specific business insights to guide data extraction and conversion from legacy systems. Data Quality & Compliance Execute data cleansing activities in accordance with project timelines and regulatory expectations (e.g., ALCOA+ principles). Validate data quality throughout the migration lifecycle, ensuring compliance with internal SOPs and external regulatory requirements (e.g., FDA, EMA). Approve and execute data verification scripts to ensure completeness, consistency, and traceability. Data Migration & System Readiness Collect and prepare data for manual or construction-related objects, including those in manufacturing execution systems (MES), LIMS, or ERP platforms. Approve upload files pre- and post-load, ensuring formal documentation and audit readiness. Perform manual data entry and dual maintenance where required, particularly in validated systems. Hypercare & Issue Resolution Act as the Single Point of Contact (SPoC) for assigned data objects during Hypercare, supporting issue triage and resolution. Collaborate with QA and IT to manage data-related defects and ensure timely remediation in line with change control procedures. Key Performance Indicators (KPIs) Regulatory-Grade Data Cleansing : Completion of data cleansing activities in accordance with project timelines and compliance standards. Validated Data Loads : Successful and audit-ready data loads into GxP systems, aligned with migration schedules. Issue Resolution Efficiency : Timely resolution of data quality issues, with full documentation and traceability. Qualifications Experience in data migration or master data management within the pharmaceutical or life sciences industry. Expertise in Supply Chain Management(SCM) and Material Management/Master Modules(MM) within SAP in a Functional or Hands off capacity Familiarity with GxP, ALCOA+ principles, and regulatory data standards (e.g., IDMP, SPOR, ISO IDMP). Proficiency with data tools and validated systems (e.g., SAP, Veeva Vault, LIMS, TrackWise). Strong analytical, documentation, and stakeholder communication skills. Understanding of data governance frameworks and regulatory compliance requirements. If you feel this role is a good fit for you - Contact me on sozay@redglobal.com or Apply within! Show more Show less

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Bengaluru and will require some on-site work. Purpose And Scope As individual contributor of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components – Digital Capability and Digital Execution . Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This dual structure enables us to scale agile practices efficiently while maintaining a focus on both product development and individual skill enhancement. A Business & Technical Analyst is a multifaceted role that bridges the gap between business needs and technical solutions. This position involves analyzing and translating business requirements into technical specifications, ensuring that the solutions developed meet the business goals and user needs. The role requires a blend of business acumen, understanding of technical architectures, and the ability to communicate effectively with both business stakeholders and technical teams. You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field. Essential Job Responsibilities Business Requirements Analysis: Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyze business processes and workflows to identify improvement opportunities and define requirements for solutions. Technical Specification Development: Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards. Solution Design and Recommendation: Work with Digital and software development teams to design solutions that fulfill business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives. Stakeholder Collaboration: Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus. Project Management Support: Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints. Testing and Quality Assurance: Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution. Training and Support: Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively. Documentation: Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared. Qualifications Required Bachelor’s degree in relevant field, e.g., Computer Science, Data Science, Business Administration. Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions. Experience with Salesforce, TrackWise Digital and Veeva platform solutions Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions. Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Familiarity with programming languages, databases, and software development tools is beneficial. Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa. Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management. Project Management: Good knowledge of Agile methodology, principles and practices. Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives. Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities. Experience with system integration and data migration Good Knowledge of ERP, Quality, Regulatory, Clinical systems and operations Preferred Life Sciences / Pharma industry experience Certifications in specific technologies, architecture frameworks (e.g., TOGAF), Agile delivery methodologies (e.g., SAFe) can be beneficial. Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery Working Environment This position is based in Bengaluru and will require some on-site work. Category PlatformX Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans Show more Show less

Purpose and Scope: Strategy Development and Execution Contributes to the implementation of 1–3-year Global, Regional Affiliate Management and Local specific objectives and plans as part of the overall PV strategy and plans. Supports in the successful execution and implementation of Global Affiliate Management vision, mission, objectives and plans. Provides input to PV leadership and strategic direction to the local PV dept in the country/affiliate. Coaching/mentoring of the local PV dept staff employees (if applicable). Responsibilities and Accountabilities: General department Executes processes and activities in which the PV department can contribute to the compliance, efficiency and overall effectiveness of the affiliate. Responsibility for executing locally new initiatives, management tools or processes in cooperation with PV-Affiliate Management Function. Provide support in ensuring that all affiliate PV staff have access to the necessary tools and systems. Effectively collaborates with the PV-Affiliate Management Function, the affiliate functions and the competent authorities. Ensure that processes, procedures and PV files are well documented in an up-to-date and complete archive i.e. ‘audit/inspection ready’ status. Management of Product Safety Information Ensures that safety information (Adverse Events) received from all sources (e.g literature search, Market Research, Patient Support, Digital Media) by the affiliate are collected, translated and forwarded to designated Regional Global PV Headquarter, in compliance with required timelines (reporting timelines), quality guidelines and standards. Ensures that all Individual Case Safety Reports (ICSRs) are captured, tracked and managed in the applicable system(s) in accordance with applicable standards and procedures. Supports in monitoring caseload trends. Provide support for monitoring interactions with vendors that are used to conduct PV services Overseeing and monitoring compliance of case documentation Is responsible for ensuring the filing, storage and archiving of Product Safety Information in the electronic archive or paper-based archive Be aware of the system(s) in place for the handling and tracking of e.g., medical information inquiries and product quality complaints Is supporting reconciliation with other Astellas operating unit systems (e.g., Medical Information and TrackWise for Quality Assurance) and contractual partners, as applicable Supports the monitoring of vendors to which PV activities have been outsourced (If allowed by local regulations) PV Quality and Compliance Conducts assigned PV activities in alignment with regulatory requirements and internal Astellas procedures to ensure full compliance with Regulatory requirements. Supports the implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicates any changes to PV Affiliate Management Function, EU-QPPV, the PV Regional HQ Office and/or other local business functions, as applicable. Executes PV activities in compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required. Supports the due diligence of potential new product acquisitions/local country licensing agreements if applicable Maintenance of PV System and Oversight Responsibilities Provides input for the PSMF regarding the affiliate communication to PV regional Head Quarters Supports in ensuring Astellas affiliate is GPvP inspection-ready: project management related to regulatory authority, business partner or internal inspections. Act as the main point of contact, and as such, coordinate regulatory authority inspections in collaboration with QA and PV: both announced and unannounced - as and when required. Supports in conducting PV self-assessments, PV audits/inspections at the affiliate and assist in developing CAPAs (with qualitative/quantitative measures and timelines) in response to findings/observations Contributes to the process of qualification of PV vendors is conducted and periodic audits are requested. Collaborates outsourced partners to ensure PV activities are conducted according to the relevant procedures Supports the establishment of contracts with Vendors and License Partners: subject to language ability. Performs activities of the Quality Management System (QMS), including QA and QC activities Supports the development and maintenance of locally applicable PV Quality documents. Ensure filing, storage and archiving of PV documentation in accordance with PV regulations and with Astellas policies and procedures. Requests to have access to, and be aware of, the affiliate business continuity plan (for example system failure and other disasters) in relation to PV activities. Responsible for ensuring a local mechanism is in place for 24/7 availability to enable appropriate handling of potential urgent safety issues by the affiliate. Contributes to the oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV. Supports in the development of safety monitoring and reporting plans for clinical trials that impact the affiliate. Ensures local post-marketing programs (e.g. Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable. Participates in local activities concerning Risk Management Plans and Risk Minimization Measures and support the implementation activities. Provides support in ensuring local initiatives such as company sponsored websites and other digital media, registries, and marketing initiatives are reviewed for compliance with PV requirements and Astellas PV procedures. Training Provides the annual delivery, and documentation of PV Product Safety Awareness training to Affiliate (e.g., Medical Information, Sales Rep, receptionists). Also, where applicable, to third party personnel providing PV-related services, and to other staff within the territory. Supports the maintenance of local PV Training Role Matrix Quality Assurance Maintain the Quality Management System: implementation and continual improvement of QM systems, procedures, and processes, i.e.: handling of deviations, complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues. Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise and TrackWise digital, are appropriately investigated and CAPA plans are developed where appropriate. Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner. Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities and perform training of the relevant Quality Management Systems. Perform local checks following receipt of certified medicinal product according to a documented process and execute the local “Release for Distribution” for products in accordance with local regulations and guidelines. Check and prepare quality agreements with local country third parties in accordance with internal and external regulations. Perform audits of local country third parties, as appropriate. Conduct self-inspections according to the approved self-inspection plan. Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems. Ensure that only approved Local Service Providers are used, if applicable. Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management. Properly document changes with potential impact on GDP/GMP compliance and implement the changes in timely manner. Perform validation activities for local GDP / GMP systems, as required. Review the Product Quality Review reports in a timely manner. Support SQI investigation and recalls. Prepare for GDP/GMP Inspections by Competent Authorities and assist the Quality Assurance Lead & Responsible Person during these inspections. Prepare and respond QA Internal audits Prepare and approve monthly KPI report and submit the KPI report to the QA Sub-region lead. Required Qualifications: Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree Track record of demonstrable and relevant minimum 3 years’ experience within PV and/or combined PV/RA/QA; to include direct contact and engagement with national competent authorities. 1 Year people/project management experience preferred. Good understanding of establishing and maintaining (GxP) Quality Management Systems. Awareness of local industry code(s) of practice and local and/or regional PV regulations and guidelines. Experience in supporting a PV system in at least one single country; low complexity, low case volume. Awareness and experience with some aspects of a PV quality management system Proficiency in local language and business English language (written, verbal, presentation, facilitation) Show more Show less