(03/11/2025) Head of Quality Assurance(TPM- Biosimilars)

5 days ago

Mumbai India Right Advisors Private Limited Full time

Job Description Primary Job Function: TPM's supplying to Biosimilars in India and APAC region - Quality Oversight of TPM's - QMS Management at TPM's - Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility - Investigations of Products failures, OOS, Complaints pertaining to Abbott products - Review of APQR's - GMP compliance at TPMs. - Compliance to Abbott procedures and policies. Core Job Responsibilities: - Responsible and accountable for the oversight of quality operations and GMP compliance across the TPM's under responsibility of EPD Biosimilars Operations in India. - Effectively monitoring the rating of responsible TPM sites. - Leading the implementation of quality strategy and plan at the TPM sites including implementation of Abbott policies. - Implement quality Projects at identified TPM's from time to time - Ensure Quality and compliance to regulatory wrt labelling, stability studies and documentation to deliver acceptable quality products coming TPM sites to consumers on sustainable basis. - Develop strategy on quality as per Abbott's EPD requirements for the supply chain organization in the third party sites in applicable region. - Promote QMS as important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors. - Create culture which imbibes quality as a way of working through identified trainings and awareness programs for assigned TPM sites. - Establish and implement a process to ensure all customer complaints/queries are addressed as per Abbott policy in stipulated time at applicable TPM sites. - Periodic quality reviews with responsible TPM QA team. Supervisory/Management Responsibilities: Direct Reports: 00 Indirect Reports: 00 Position Accountability/Scope: - To identify training needs and support the TPM for Biosimilars portfolio - Monitor and ensure complaints are closed within timelines with adequate investigations. - Complete QA review and approval for FLQR on time , change control, exception documents for QA standpoint - Ensure supply and commitment to regulatory filings in markets. - Ensure change controls are assessed in a complaint manner and the products are supplied to respective markets only when changes are approved. Minimum Education: - M Pharm, M.Sc Biochemistry, Microbiology or equivalent Minimum Experience/Training Required: - Total experience (in years): Minimum 12 years - Experience in Quality function of a Biosimilar site is a positive

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