292 Trackwise Jobs

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Senior Manager As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Senior Manager 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, identify automation opportunities and drive internal initiatives. The opportunity We’re looking for Senior Manager with expertise in Life Sciences Regulatory Compliance and Stakeholder Management to join the leadership group of 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 Client Responsibilities Participate and lead Regulatory Compliance engagements Help manage the financial aspects of engagements by organizing staffing, tracking fees, and communicating issues to project leaders Drive-in business development initiatives along with client management and account management Build strong internal relationships within Risk Consulting practice and with other services across the organization Build connect with client stakeholders, understand their business challenges/pain areas and work with leadership to propose innovative solutions People Responsibilities Develop people through effective coaching and mentoring Conduct performance reviews and contribute to performance feedback Contribute to people-related initiatives including recruiting, retaining, appraisal and training Contribute towards building and strengthening team competency for Regulatory Compliance and Risk consulting Participate in the organization-wide people initiatives Maintain an educational program to develop skills of team members continually Decision-Making Responsibilities: Support management in workforce planning, resourcing strategy, go to market strategy and demand generation Understand the business requirements clearly and lead practice development initiatives as required Bring out of the box thinking mindset, and analytical thinking capability to enhance service delivery Always maintain connections with clients to tap opportunities for constant growth and improvement Understand the process gaps and propose preventive/corrective action where appropriate Lead business growth, pursuits and client proposals for Enterprise Risk/Regulatory Compliance, directly working with the regional partners and Associate Directors. Other Responsibilities Actively contribute to the IT applications project management initiatives that includes Validation/Qualification/Variance Management 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. 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 Identify opportunities in existing accounts to cross-sell other EY services. Planning and monitoring of the project deliverables from the team. 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. Regular status reporting to the Associate Directors, Partners, Directors and onsite coordinators. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Demonstrate flexibility to travel to the customer locations on need basis Conduct performance reviews and contribute to performance feedback for staff, senior and managers Foster teamwork, quality culture and lead by example Understand and follow workplace policies and procedures Training and mentoring of project resources Participate in the organization-wide initiatives Lead practice initiatives and portfolios Market trend +Digital trends. Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Quality & Compliance managed services and Consulting experience in of Life Sciences Domain. Sound domain knowledge in Pharmaceutical industry in the areas of Quality and Compliance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Strong knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Versed with ICH guidelines, ISPE framework on Risk management, System Development Life Cycle concepts. 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. Strong knowledge of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. as they relate to Computer Systems Strong understanding of Data Integrity requirements Governance and reporting Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures. Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Has supported Audits / Inspections To qualify for the role, you must have MBA/B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance/Life Sciences outsourcing companies Good interpersonal skills; Good written and presentational skills At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations Experience in managing team and solution designing 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 Project Management 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.

Role Description HPLC (Empower software), GC, Ion Chromatography, Dissolution apparatus knowledge (desirable for PSD, Titrimetric analysis) Must be working in cGMP Laboratory. Dissolution on different media for Various market Method Validation/Verification for drug products Working on eLIMS, Trackwise, eDMS, (compulsory) Good analytical skills Qualifications Master's degree in chemistry, Pharmacy, or related field

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 Senior Migration Consultant will be a leading member of the Veeva Systems Professional Services group providing migration solutions for our global project teams implementing Veeva Vault R&D applications and Vault Platform cloud solutions to companies in the life sciences industry. The Senior Migration Consultant will lead customer migration implementations by providing expertise in data and document content migration, Vault API, Vault migration tools, and Vault Platform best practices. The Senior Migration Consultant is a customer advocate who works closely with other Veeva teams (Services, Product, Sales, Strategy) to ensure customer success today and in the future. This is a remote, full-time, permanent role with Veeva. What You'll Do Provide subject matter expertise on the Vault R&D migration implementation, including the migration of document content and object data from legacy systems to Vault Advise customers on the extract, transform, and load (ETL) process Mentor Veeva Data Migration Specialists on migration activities and best practices Contribute to our knowledge base to build a migration program Provide guidance and subject-matter-expertise on migration tool development for the ETL process Assist in project scoping estimates for the Vault R&D product suite Requirements 7+ years of experience with document/content migration experience with enterprise content management systems (Documentum, OpenText, Box, SharePoint, etc.) 7+ years of experience in implementation or data migration or integration consulting with enterprise software systems (SAP, Salesforce.com, PeopleSoft, Oracle, Trackwise, Argus, ArisGlobal, etc.) 7+ years of customer-facing technical consulting experience Advanced-level skills with SQL and databases Advanced-level skills with Python/Java, REST APIs Excellent presentation skills, verbal & written communication skills Strong organizational and interpersonal skills Nice to Have Experience with the Pharmaceutical and Life sciences industry Experience with Clinical, Quality, Regulatory, or Safety business processes Experience in data migration or integration consulting Experience with Project Management for enterprise implementations/migrations Experience with Content Management Systems such as Documentum, Trackwise, Sharepoint Experience with GxP and software validation regulations Experience with Veeva Development Cloud applications 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.

KEY JOB REQUIREMENTS: In this role, you will be successful, if you have: Qualification • Bachelor or Master of Science, preferably: Biomedical, Mechanical Engineering, Biotechnology, Biochemistry, Pharmacy or similar Experience: • At least 3 to 5 years of experience including experience in leading teams and managing daily operations, preferably in complaint management • Experience in complaint database such as SAP, Trackwise, Salesforce etc. • Holds knowledge of monitoring and tracking of report submission in accordance with related standards, regulatory timelines • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint) Key Responsibilities • Medical devices Complaint handling- Complaint processing including Complaint Intake, Product details, Triage, Decision tree, Complaint closure • Vigilance reporting • IMDRF and FDA codings • Complaint investigation • Due diligence • Mailbox monitoring and handling Responsibilities may include the following and other duties may be assigned • Evaluates incoming complaint information and maintains the record in the electronic database. • Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints. • Determines Reportability of complaints to regulatory bodies. • Identify and document appropriate complaint categories to assure trend accuracy within the complaint database. • Writes investigation summaries based on technical product analysis information provided • Prepare and submit the MedWatch-3500A Report, MIR Report, Initial, Follow-up, and Final Reports to the respective competent authorities in compliance with regulations, guidelines, and the required timeframe. • To check the customer feedback and initiate follow-up for additional information • Performed coding activities on the assigned projects with timelines and efficiency. • Assure the accuracy, integrity, completeness, and consistency of all product complaint investigations of MDR and other Vigilance reports. • Have clear understanding of KPIs. • Diligently follow relevant SOP of the project • Understanding the Responsibility of Timely Escalation of significant events to the Team Lead/Manager. • Performed QC on all types of records and other related duties as directed by management • Ensures record documentation is maintained in a constant state of audit readiness per internal policies. • Liaison with groups who perform additional investigation and who prepare written record of investigation. • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing. • Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting Tools Expertise TrackWise, SAP, Salesforce, Microsoft applications (Excel, PowerPoint)

Project Role: IT Compliance Advisor Experience: 4-7 years Job Location: Bengaluru/Pune/Kochi Work Mode: Hybrid Must Have Skills: Compliance, Validation and Testing, GXP, System life cycle Domain Knowledge: Healthcare, CRO, Life Science Job Description Summary: Compliance and Validation Hands-on experience in compliance and validation roles Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 System validation aligned with regulatory standards Review of validation artifacts and identification of traceability or documentation gaps System Life Cycle and Methodologies Well-versed with System Life Cycle Hands-on experience with Validation approach, Agile methodology, AIML concepts Testing/Validation Experience Review and preparation of: Test Plans, Validation Plans, Risk Assessments Requirement Traceability Matrix (RTM), Summary Reports Understanding of the defect lifecycle and validation deliverables Tools and Technologies Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems Quality & Domain Expertise Knowledge of Quality Management Systems (QMS) Experience in Healthcare, CRO, or Life Sciences environments Good to Have Skills : Experience with SaaS validation, automation, and vendor audits Participation in internal/regulatory audits Strong documentation skills (SOPs, templates, work instructions) Familiarity with risk-based validation and data management Educational Qualification: Any Graduate

Job Title Executive / Sr. Executive QA Business Unit Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc.) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M.Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Title Sr. Officer / Executive QA Business Unit Global Quality & Compliance Job Grade G12B /G12C Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review or verification to ensure adequacy, completeness and compliance of documents, procedure, practices, etc. Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. To report Rejection/Failure observation immediately. Preparation and review of GMP documents related to activities. Release/Reject of material/batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/transactions in SAP System Follow the labelling and seal issuance procedure for materials after release/ rejection of batches. Involved in dispatch activity and customer COA preparation/ to Verify certificate of analysis. Equipment, instrument and utilities etc. qualification and re-qualification protocol and report review for manufacturing section. To co-ordinate with change control team for the evaluation of change controls to refer for impact assessment and to derive action items. Review and closure of the change controls/action items in track-wise. To escalate or highlight problems in QMS documents, investigations, BMR, ECR and another document time to time. To involve in training, internal audits, external audits (Regulatory and customer). Preparation and review of product quality review (APOR/POR) and stated documents as per schedule, monthly report and as and when required Responsible for co-ordination, monitoring, tracking, participating etc in activities assigned for review verification to ensure adequacy, completeness and compliance of documents, procedure, To monitor, Tracking, review/closing of deviations, Out of specification, Investigation. Corrective and Preventive actions, Market complain, Change controls, etc to ensure adequacy in quality management system (QMS) Participation in various investigation processes (including cross functional investigation) to identify root cause and derive appropriate CAPA, etc. and closing the CAPA action/QMS documents Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, esc GMP Walk round in manufacturing plants, Quality Control Laboratory, stores, engineering as per schedule. Review of annual summary reports for water systems and annual summary reports for environmental monitoring Travel Estimate Job Requirements Educational Qualification M.Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 5 to 8 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Job Title Executive / Sr. Executive QA Business Unit Global Quality & Compliance Job Grade G12A / G11B Location : Ahmednagar / Ahilyanagar At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key Responsibilities Responsible for co-ordination, monitoring, tracking, participating, etc. in activities assigned for review/verification to ensure adequacy, completeness and compliance of documents, procedure. practices, etc. To monitor, tracking, review & closure of deviations, Out of specification, Investigations. Corrective and Preventive actions, Market complaint. Change controls, etc. to ensure adequacy in quality management system (QMS). Ensure effective implementation of Quality Management system at site and to monitor QMS activities in Track wise software. To escalate or highlight problems in QMS document and investigation in time. Review of data with evaluation to support of QMS documents like Change controls, deviations, CAPAS, OOS, Laboratory Events & monitoring of Preventive Maintenance, qualification etc. Responsible for co-ordination, monitoring, tracking and review of documents related to validations like process performance qualification, cleaning validation, Matrix, continued process verification report, etc. To provide the required details/data related to QMS for the preparation of APQR, monthly report and as and when required. Preparation/review of APQR Preparation/guidance and review of Quality Risk Management evaluation of risk involved in manufacturing activities, received / manufactured material, related to audit compliance, failure/gaps of existing system, activities related to laboratory controls, etc. Review of change controls received from different departments (viz. process, equipment, facility. SOP, specification, etc.) for its appropriate evaluation, justification and its classification to identify and communicate the action items derived based on the assessment to all the concern wake holder through Trackwise. Providing the status of QMS records like change controls, deviations, etc. as an when required to management through Quality metrics, data gathering, etc and to conduct the meeting for its progress and timely closure. Coordinating and reviewing technology transfer activity and ensuring availability of required documents as per respective SOP Review of Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures. Release Reject of material batch in SAP HANA after ensuring related relevant documents and system related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed etc. are closed prior to approval. Activities related to updation/ transactions in SAP System Perform the product change over clearance activity in manufacturing, packing/repacking area. To operate various software such as Trackwise, SAP, LIMS, BRMS, EDAMS, EDMS etc. Travel Estimate Job Requirements Educational Qualification M.Sc. (Organic Chemistry / Analytical Chemistry) Experience Tenure : 7 to 9 yrs experience in API manufacturing Units in Quality dept Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

What you will do: Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings Coordinates microbiological and/or chemical testing Review and approval quality records/ validations Troubleshooting/ NC Handling/ Supplier Management/ communication High Quality in Micro & Sterility Perform Monitoring Oversight / Data Trending Procedure Owners to Drive CAPAs/ Improvements Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP) Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA What you will need: Coordination, delegation, communication, stress, resiliency Relentless Quality First ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM) SME core competencies Product Cleanlines Cleanroom/ Environmental Monitoring/ Testin Sterilization (EO) English and German or French 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

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem Group of Companies’ suppliers encompassing audit scheduling, execution, reporting, follow-up and closure of the audits. Accountable for adhering to the requirements of the Apotex’s Quality Manual, policies, procedures; and applying all regulatory standards such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA, when conducting audits. Responsible for recommending audit system enhancements based on the learnings leveraging the existing system/field experience and collaborating with management to ensure continuous compliance, development & improvement of the Corporate Quality Audit program. Job Responsibilities Execute Corporate and supplier audits such as first GMP, routine, Targeted Technical Assessment (TTA) and For-Cause audits in accordance with Apotex’s SOPs and current GMP regulations Adopt the best practices of Excellence in Partnership to develop and sustain effective relationships with Apotex sites, suppliers, contractors, and business partners Perform Due Diligence audits of potential new Apotex suppliers, generate reports and provide recommendations pertinent to suitability and sustainability of the quality and compliance of new suppliers. Propose remediation plans to mitigate risks that could be impeding the future stability of Apotex supply chain Liaise with Apotex Enterprise sites to evaluate the leading indicators such as QPIs prior to conducting site audits to ensure high risk areas are included as part of the site audit scope. Communicate potential non-compliance aspects of the audit outcome with the applicable site leadership team and escalate to Apotex Escalation Committee (AEC) as appropriate Research and compile all available supplier quality/procurement data such as complaints, investigations/deviations, recalls in Apotex systems (SAP, QMS TW, LIMS, etc.) and external systems (e.g. Health Canada, FDA, MHRA websites) to ensure high risk areas are included as part of the audit scope. Perform Risk Profiling of Apotex suppliers for Predictive Analytics to determine the audit frequencies based on the risks Compile precise, accurate and chronologically factual audit reports within the allotted time to enable meaningful review and approval of the audit reports Communicate the identified deficiencies and compliance risks to appropriate business stakeholders such as Global Active Pharmaceutical Ingredients (GAPI), External Manufacturing Quality (EMQ), Supplier Quality (SQ), Business Development (BD), Apotex Site Heads and Global Supply & Technical Operations (GSTO) Support the sites with developing and executing remediation actions to drive sustainable compliance to regulatory and Apotex’s standards. Evaluate the appropriateness of proposed CAPAs and remediation plans, monitor the progress and evaluate the effectiveness of the CAPAs implemented Provide authoritative technical and regulatory guidance/direction to internal and external stakeholders pertinent to regulatory compliance Provide expert inspection and logistics support during inspections of Apotex sites by regulatory agencies and customers when requested Prepare, update and review proposed changes to SOPs Share knowledge, collaborate with auditors across the regions to enhance expertise in different disciplines and to mentor/coach new & existing auditors Review emerging/ever-changing regulatory landscape, standards & inspection trends to stay a step ahead of the regulators in protecting Apotex’s interests internally and externally Fiscally responsible for spending in accordance with company policy and to accomplish budget targets favourable to plan Accountable for meeting individual and departmental monthly, quarterly and yearly audit metrics Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education University degree in science or Regulatory affairs related program Background in pharmaceutical/chemical sector would be an asset Knowledge, Skills and Abilities Excellent knowledge in current good manufacturing regulations and standards as applicable to the pharmaceutical industry such as ISO, Health Canada, FDA, EU/EMEA, MHRA, PIC/s, ANVISA and TGA Expertise in at least one specific area: non-sterile manufacturing, sterile manufacturing, biopharmaceuticals, medical devices, API, excipients and intermediates is preferred. Ability to review and comprehend the requirements of ICH, WHO, EXCiPACT, ISO, IPEC, ISPE, etc. guidance documents Clear and concise written and verbal communication in Apotex’ s language of business Demonstrated organizational skills and strong attention to details Demonstrated ability to effectively manage multiple priorities in a fast-paced environment Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict confidentiality when exposed to, and handling, sensitive and confidential information Work independently or in a team setting to achieve individual, departmental and organizational goals Advanced computer skills, including Microsoft Office Products Working knowledge with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP) and Laboratory Information Management System (LIMS) would be an asset Experience Minimum 10 years of relevant experience in the Pharmaceutical industry with a minimum of 5 years spent in Quality operations, Quality Assurance and Quality Audits Working knowledge and/ or hands-on experience with the other Pharmaceutical Quality Systems would be an asset At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Work Flexibility: Hybrid What you will do: Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings Coordinates microbiological and/or chemical testing Review and approval quality records/ validations Troubleshooting/ NC Handling/ Supplier Management/ communication High Quality in Micro & Sterility Perform Monitoring Oversight / Data Trending Procedure Owners to Drive CAPAs/ Improvements Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP) Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA What you will need: Coordination, delegation, communication, stress, resiliency Relentless Quality First ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM) SME core competencies Product Cleanlines Cleanroom/ Environmental Monitoring/ Testin Sterilization (EO) English and German or French Travel Percentage: 10%

Job Id 290654 Bangalore, Karnataka, India Job Type Full-time 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 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 ERPs 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! and become a part of our diverse team! US Equal Employment Opportunities The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Notice on Fraudulent Job Offers Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here. Applicant Profile Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you’ve will completed, and any in the future, you can create a new profile to check in on your status. WHAT WE OFFER Money makes the world go round. But at our company there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic. Saving & Finacial Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year. We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future. Health & Wellness We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program. We also offer a wellness incentive program and personalized support to help you navigate and use your benefits. Voluntary Benefits Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance. We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans. Work/Life Support We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more. OUR RECRUITING PROCESS Depending on the position (level, functional area, country) the process can vary slightly. You apply Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity. We screen We review your application and if we determine that you are a good fit we will move you to the selection process. We assess You are interviewed by phone, via video and/or face to face. Mutual agreement Ideally you are the perfect match for us! We hope you consider us as your new employer. Work your magic! To guarantee you a smooth start our onboarding preparation begins. Haven’t found the right job yet? Join our Talent Community to stay connected and explore future opportunities.

Job Description What you will do: Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings Coordinates microbiological and/or chemical testing Review and approval quality records/ validations Troubleshooting/ NC Handling/ Supplier Management/ communication High Quality in Micro & Sterility Perform Monitoring Oversight / Data Trending Procedure Owners to Drive CAPAs/ Improvements Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP) Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA What You Will Need Coordination, delegation, communication, stress, resiliency Relentless Quality First ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM) SME core competencies Product Cleanlines Cleanroom/ Environmental Monitoring/ Testin Sterilization (EO) English and German or French Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Job Details Role Level: Associate Work Type: Full-Time Country: India City: Gurugram ,Haryana Company Website: http://www.stryker.com Job Function: Information Technology (IT) Company Industry/ Sector: Appliances Electrical And Electronics Manufacturing Medical Equipment Manufacturing And Industrial Machinery Manufacturing What We Offer About The Company Searching, interviewing and hiring are all part of the professional life. The TALENTMATE Portal idea is to fill and help professionals doing one of them by bringing together the requisites under One Roof. Whether you're hunting for your Next Job Opportunity or Looking for Potential Employers, we're here to lend you a Helping Hand. Report Similar Jobs Senior Solution Lead ERP Talentmate Associate MPS Talentmate Specialist Sr Specialist Regulatory Affairs Talentmate Project Manager - Product Security Talentmate Lead Sales Representative - UAE National Only Talentmate Specialist Regulatory Affairs Talentmate Disclaimer: talentmate.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@talentmate.com.

What you will do: Coordinates microbiological and/or chemical testing, release of product and testing for validation protocols. Performs organism identification. Performs technical review of batch filling records to ensure quality of aseptic processes. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. May perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. Reviews and approves environmental monitoring data and laboratory equipment and records. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness. Daily Business coordinator in Micro & Sterility e.g. for Dose Audit programs/ bioburden Monitorings Coordinates microbiological and/or chemical testing Review and approval quality records/ validations Troubleshooting/ NC Handling/ Supplier Management/ communication High Quality in Micro & Sterility Perform Monitoring Oversight / Data Trending Procedure Owners to Drive CAPAs/ Improvements Reg. Compliance (Internal/ External Audits, Tech Files, Standards, ISO 19227, law, GMP) Process Control/ Validation Strategy for Micro/ Cleaning/ Sterility SME for Major Changes/ PT (GIA MicroBio) + Support NPI / monitoring devitations/ alerts/ action limits/ NC/ CAPA What you will need: Coordination, delegation, communication, stress, resiliency Relentless Quality First ValGenesis, NC/CAPA (Trackwise), Change Management (OnePLM) SME core competencies Product Cleanlines Cleanroom/ Environmental Monitoring/ Testin Sterilization (EO) English and German or French Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Job Title Smart Connected Products > + + Management Level:07 - Manager Location:Bangalore/ Must have skills:Have Experience with leading MedTech solutions effectively by providing value-add to the processes, designs, methodologies, and business models Good to have skills: Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Experience:10+ years of Industry Experience Educational Qualification:Engineering background with MBA preferred Job Summary: As part of the Smart Connected Product Design & Development (SCPDD) team you will create Connected Products based solutions in the MedTech space that provide vital digital intelligence and drive organizational changes for some of the world's best product companies. Roles & Responsibilities: - Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Demonstrate leadership skills along with strong communication, problem solving, organizational and delegation skills Qualification Professional & Technical Skills: At least 10+ years in MedTech and Life Sciences across the value chain with experience to lead Strategic Projects with a global top Pharmaceutical, Medical Devices, Biotechnology or Healthcare Consulting firms Experience with QMS development and alignment from beginning to end of project cycle and be comfortable working with and according to the industry norms and existing processes. Comfortable with platforms including Trackwise, Veeva etc. Experience of developing commercialization strategy and launching medical devices in new markets End to End development of Personal Health Record (PHR) System as per HL7 PHR-S Functional Model Experience with integrating new technologies for EMR & PHR and medical devices Understanding of In-Hospital and remote fetal monitoring system, Remote ECG Monitoring system and Medical Device connectivity with EMR system Understanding of gateway connectivity with EHR, PACS and multiple devices such as C-Arm, Ultrasound, Laser, saline devices etc. Implementation of Healthcare Information System (HIS), Radiology Information System (RIS), Pharmacy Solution & e-Health solution at Healthcare Providers In-depth understanding of Medtech, Digital health, Cybersecurity, Connected Health Strategy (DTx and SaMD), Point of care diagnostics and Digital/Robotics Surgery Experience in business scoping, assessment and planning that includes Blueprinting, business case creation and business process redesign Experience in Project Management:Transform Product Strategies, Product Management, and overall engineering by enabling portfolio alignment with overall business strategy, right products mix with optimal resource utilization and better governance thereby ensuring increased product success Develop assets and methodologies, point-of-view, research or white papers for use by the team and larger community Lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with clients business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Additional Information: Exceptionally organized Detail oriented Good judgement in how to engage with senior stakeholders regarding approvals/ follow ups Strong communication skills Proactive and able to work independently Sensitivity and skill at working with different cultures and styles A highly motivated self-starter

As part of the Global IT Team, this position will lead the harmonization of Quality Management System (QMS) solutions, from a technology perspective, and the implementation and stabilization of Veeva Vault as a global eQMS software solution, working closely with leadership in the RA/QA organization. On a daily basis, this lead will drive the implementation and support of Veeva Vault as the technology platform enabling a transformation of Bio-Rad’s Quality Management Systems onto a modern, harmonized application that reduces risk, enhances proactive issue detection, standardizes reporting, supports a culture of quality, and is scalable and sustainable for Bio-Rad’s future growth. How The Candidate Will Make An Impact The position will focus on eQMS software and supporting processes. The major areas of scope Non-Conformance (NC) CAPA Audits Document Control and Management Relevant Life Science Industry experience, including SOX and GxP is highly desired Sound business and IT acumen Be able to design processes and sub-processes and to think through the implications of those designs Have experience with systems implementation and/or process transformation Implementation and Support experience with leading eQMS solutions such as Veeva, Sparta Trackwise Digital, ETQ Reliance, MasterControl, Compliance Quest, PTC Arena, or others Have experience documenting processes “as is” through process maps and SOP’s and have a working knowledge of business process decomposition techniques Strong Business Knowledge – Ensures the Veeva Vault technology supports best practices business processes. Well Rounded IT Professional – Ability to present to executives while also collaborating with developers to deliver technology solutions. Partnership - Working daily with an industry leading systems implementation firm to deliver this Quality. Management System transformation. What The Candidate Brings Qualifications - Top 5 required attributes, skills, and work experience Implementation and Support Experience with Veeva Vault or other leading QMS Systems. Masters or Bachelor’s degree in Computer Sciences, Engineering, or equivalent Proven leader that builds and fosters open working team environments Experience with international business processes and relationships a strong plus Process Documentation experience. Relevant Life Sciences Industry Experience highly desired. Proven ability to establish critical relationships and build trust and credibility throughout the organization. Have demonstrated working with IT managers and business owners to formulate actionable plans and solutions Thinks cross functionally and makes sound business decisions. Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees through the various stages of an employee’s work and life cycle. We’re proud to offer a variety of options, including competitive insurance plans for you and your immediate family, Annual Health checkup , Marriage Leave, Paternity Leave ,Employee Assistance Programme , extensive learning and development opportunities, and more. EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply. Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. Legal Entity: (IND_3006)Bio-Rad Laboratories (India) Pvt Ltd

About The Role Job Title : Smart Connected Products - Manager-S&C GN Management Level:07 - Manager Location:Bangalore/ Must have skills: Have Experience with leading MedTech solutions effectively by providing value-add to the processes, designs, methodologies, and business models Good to have skills: Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Job Summary : As part of the Smart Connected Product Design & Development (SCPDD) team you will create Connected Products based solutions in the MedTech space that provide vital digital intelligence and drive organizational changes for some of the world's best product companies. Roles & Responsibilities: - Have business Acumen to drive actionable outcomes for clients Possess analytical and outcome-driven approach Demonstrate a strategic Mindset to understand shape innovative, fact-based strategies and operating models Ability to communicate and present skills to share the perfect pitch with key stakeholders Have team building skills to collaborate, work and motivate teams with diverse skills and experience to achieve goals Demonstrate leadership skills along with strong communication, problem solving, organizational and delegation skills Professional & Technical Skills: At least 10+ years in MedTech and Life Sciences across the value chain with experience to lead Strategic Projects with a global top Pharmaceutical, Medical Devices, Biotechnology or Healthcare Consulting firms Experience with QMS development and alignment from beginning to end of project cycle and be comfortable working with and according to the industry norms and existing processes. Comfortable with platforms including Trackwise, Veeva etc. Experience of developing commercialization strategy and launching medical devices in new markets End to End development of Personal Health Record (PHR) System as per HL7 PHR-S Functional Model Experience with integrating new technologies for EMR & PHR and medical devices Understanding of In-Hospital and remote fetal monitoring system, Remote ECG Monitoring system and Medical Device connectivity with EMR system Understanding of gateway connectivity with EHR, PACS and multiple devices such as C-Arm, Ultrasound, Laser, saline devices etc. Implementation of Healthcare Information System (HIS), Radiology Information System (RIS), Pharmacy Solution & e-Health solution at Healthcare Providers In-depth understanding of Medtech, Digital health, Cybersecurity, Connected Health Strategy (DTx and SaMD), Point of care diagnostics and Digital/Robotics Surgery Experience in business scoping, assessment and planning that includes Blueprinting, business case creation and business process redesign Experience in Project Management:Transform Product Strategies, Product Management, and overall engineering by enabling portfolio alignment with overall business strategy, right products mix with optimal resource utilization and better governance thereby ensuring increased product success Develop assets and methodologies, point-of-view, research or white papers for use by the team and larger community Lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Execute a transformational change plan aligned with clients business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Additional Information: Exceptionally organized Detail oriented Good judgement in how to engage with senior stakeholders regarding approvals/ follow ups Strong communication skills Proactive and able to work independently Sensitivity and skill at working with different cultures and styles A highly motivated self-starter About Our Company | Accenture Qualification Experience: 10+ years of Industry Experience Educational Qualification: Engineering background with MBA preferred

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. Job Description Analyst – Order Management Location: Bangalore – Electronic City 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. Customer focused approach. Process customer documentation requests. Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. Essential Job Functions Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Provide documentation support to customer using multiple tools. 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. Creating and updating standard operating procedures for the process. Identifying and giving training on process to the team. Should work as a unit of the team to deliver daily set goals and achieve set TAT and quality. Recommend and participate in process improvement studies. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Attending review meetings with stakeholders where necessary. Exemplary attendance and adherence to schedule. Work on Adhoc requests when assigned. Establish Company’s values through daily operations. Should process orders and assist customer queries as per the region with the set expectation. Who You Are Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP, Oracle. 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, Oracle SFDC Understand the basics of the Marketing Business knowledge and should be quick learner. Should possess basic knowledge of Microsoft Office (Word, Excel, PowerPoint). Technical Knowledge related to documentation. Effective follow up of the requests. 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!

Greetings from Compliance Quest, ComplianceQuest was founded in 2013 and is based in Tampa, Florida.ComplianceQuest is a highly flexible 100% cloud based EQMS built using the Salesforce platform.ComplianceQuest is a next generation modern cloud platform with AI powered solutions for Clinical,Quality, Health and Safety and Environment natively built and run on Salesforce technologies.We help our customers of all sizes deliver quality products and services in the safest,most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers,employees, suppliers and brand. Roles and Responsibilites: Provide consulting services to assigned projects as required, including product functional consulting, business process re-engineering, customization requirements, product validation and custom report analysis. Provide Product training to customers as required on the modules that the Sr. Consultant is certified in. Continue to improve knowledge of CQs solution, quality standards, industry, and technology to better serve the internal and external customers. Proactively improve one’s productivity and quality. Participate in refresher training classes to renew certification and new training classes for new products, quality standards, industry, and technology. Provide product and industry training to company employees as assigned. Timely and quality delivery of project deliverables in accordance with the project’s schedule and timeline under the direction of the project manager. Escalate any issues that cannot be immediately resolved to the project manager in charge of the team. Ensure that appropriate reports are written for all the appropriate deliverables.

Company Description Epitome Components Limited is a leading PCB manufacturer in India, known for its advanced infrastructure and substantial production capacity of 100,000 sqm per month. The company serves a vast customer base across India and abroad, including notable clients like Videocon, LG, Nokia, Thomson, Phillips, Pricol, and others. Epitome has formed a joint venture with the UK-based company Trackwise Designs Ltd. to manufacture RF Antenna PCBs for cellular networks, radar, space industry, and various high-end applications. Position: Sales Executive Experience: 2 - 5 years Education: Any Graduate Fluent English Good Presentation Skills we are looking for a highly motivated and experienced Sales Executive to join our team in the Electronics PCB Manufacturing industry. The ideal candidate will have 2-5 years of experience in sales, preferably in B2B sectors. Roles and Responsibility · Develop and execute sales strategies to achieve business objectives. · Build and maintain strong relationships with corporate clients and identify new business opportunities. · Conduct market research to stay updated on industry trends and competitor activity. · Collaborate with cross-functional teams to drive sales growth. · Analyze sales data and provide insights to improve sales performance. · Identify and pursue new business leads through networking and cold calling. Job Requirements · Proven experience in sales, preferably in B2B sectors. · Strong understanding of the electronics manufacturing industry. · Excellent communication and interpersonal skills. · Ability to work independently and as part of a team. · Strong problem-solving and analytical skills. · Familiarity with sales software and tools. · Experience working with Electronic Manufacturing preferred.

Job Id 289693 Bangalore, Karnataka, India Job Type Full-time 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. Job Description: Analyst – Order Management Location: Bangalore – Electronic City 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. Customer focused approach. Process customer documentation requests. Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. ESSENTIAL JOB FUNCTIONS: Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Provide documentation support to customer using multiple tools. 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. Creating and updating standard operating procedures for the process. Identifying and giving training on process to the team. Should work as a unit of the team to deliver daily set goals and achieve set TAT and quality. Recommend and participate in process improvement studies. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Attending review meetings with stakeholders where necessary. Exemplary attendance and adherence to schedule. Work on Adhoc requests when assigned. Establish Company’s values through daily operations. Should process orders and assist customer queries as per the region with the set expectation. Who You are: Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP, Oracle. 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, Oracle SFDC Understand the basics of the Marketing Business knowledge and should be quick learner. Should possess basic knowledge of Microsoft Office (Word, Excel, PowerPoint). Technical Knowledge related to documentation. Effective follow up of the requests. 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! and become a part of our diverse team! US Equal Employment Opportunities The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Notice on Fraudulent Job Offers Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here. Applicant Profile Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you’ve will completed, and any in the future, you can create a new profile to check in on your status. WHAT WE OFFER Money makes the world go round. But at our company there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic. Saving & Finacial Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year. We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future. Health & Wellness We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program. We also offer a wellness incentive program and personalized support to help you navigate and use your benefits. Voluntary Benefits Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance. We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans. Work/Life Support We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more. OUR RECRUITING PROCESS Depending on the position (level, functional area, country) the process can vary slightly. You apply Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity. We screen We review your application and if we determine that you are a good fit we will move you to the selection process. We assess You are interviewed by phone, via video and/or face to face. Mutual agreement Ideally you are the perfect match for us! We hope you consider us as your new employer. Work your magic! To guarantee you a smooth start our onboarding preparation begins. Haven’t found the right job yet? Join our Talent Community to stay connected and explore future opportunities.

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

Description Regulatory Consultant (CMC/ EU Market Exp) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. Qualification Requirements Should have 5+ years total work experience and 4+ years relevant experience in Regulatory Affairs. Should have markets experience in EU (mandatory) , GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) , MEA MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, good attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Provide regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC) and other lifecycle maintenance activities. An experience in product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams, would be preferred.

Description Regulatory Consultant (CMC/ EU Market Exp) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. Qualification Requirements Should have 5+ years total work experience and 4+ years relevant experience in Regulatory Affairs. Should have markets experience in EU (mandatory) , GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) , MEA MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions. Excellent interpersonal / communication skills including excellent written and verbal communication skills. Excellent customer service skills, with the ability to work both as a team member and independently. Good quality management skills. Advanced skills in Microsoft Office Applications. Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred. Ability to interact with staff from multiple departments and offices to establish project standards. Good initiative, adaptability, and pro-activity. Strong analytical skills, good attention to detail. Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Provide regulatory and technical support for assigned CMC post-approval variations, renewals, annual reports, legal entity name changes (LENC) and other lifecycle maintenance activities. An experience in product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams, would be preferred.

Job Title Location IT Lead Job Grade G9B Function Global Information Technology Sub-function Manufacturing & Quality IT Manager’s Job Title API & RND India Cluster 2 Lead Skip Level Manager’s Title API & RND India IT Head Function Head Title Global Chief Information Officer Location: Ahmednagar Areas Of Responsibility At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” The Job holder will be responsible for all aspects of frontend IT support including IT infrastructure, Application support, Quality IT, Manufacturing IT, and CSV. Additionally, ensure compliance with regulatory requirements, support audits, manage IT-related procurement and handle payment processes for the site. The Job holder will ensure the smooth IT operations at the site. Management of IT Infrastructure, Inventory for hardware and software. Backup-Restoration, Archival-Retrieval of electronic data. Resolving on going Hardware /Software Problems with the support of FMS team at the site and Corporate teams. Management of Quality informatics, Laboratory Applications Chromatography (CDS)/Non-Chromatography (Non-CSD) such as Water’s Empower, Chromeleon , Lab-X etc. Management of Manufacturing informatics such as Data Loggers, PLCs, SCADA & DCS systems. L1 support to all global application like EDMS, LMS, Trackwise, SAP-HANA, and LIMS. Contribute for preparation of IT SOPs, CSV - Computer system qualification & validation, Maintain IT regulations & compliance, regulatory audit support. To perform and participate in QMS activities such as Change Controls (CCRs), Incidents, Deviations and Corrective & Preventive Actions (CAPAs). Follow-up to close all CCR/Deviation/Investigation/CAPA related to all infra system in a timely manner. To support Implementation of site-based projects and Global projects at the site. Coordination with internal and external stakeholders for various application support and project execution. Understanding of IT security policies, domain policies, malware and antivirus. Procurement & payment process management. People Management process for IT Team Travel Estimate Need Based Job Scope Internal Interactions (within the organization) Plant Management, Business Users, Corporate IT Teams, Quality and CSV Teams External Interactions (outside the organization) Various Service providers, Vendors, Customers, Regulatory Auditors. Geographical Scope Directly Manage site IT operation and at the same time provide onsite / offsite support to another site whenever needed. Financial Accountability (cost/revenue with exclusive authority) Based on Approved Budgets for the sites – Both Opex & Capex Job Requirements Educational Qualification BE/B. Tech, MCA, BCA, MSc.-IT, BSc.-IT, Graduation + PGDCA. Specific Certification NA Skills IT Infrastructure Management, CSV Support, IT regulatory requirements, Quality Informatics and Manufacturing Informatics. Experience 7 - 8 Years in IT Operations, Preferably in Pharma Manufacturing. Your Success Matters to Us At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).