Head \u2013 TPMQA India - Biosimilars
ConfidentialMumbai, India5 days ago
Job descriptionResponsible 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. 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 Abbott markets. Ensure change controls are assessed in a complaint manner and the products are supplied to respective markets only when changes are approved. M Pharm, M.Sc Biochemistry, Microbiology or equivalent Total experience (in years) : Minimum 12 years Experience in Quality function of a Biosimilar site is a positive
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 :
Supervisory / Management Responsibilities :
Direct Reports : 00
Indirect Reports : 00
Position Accountability / Scope :
Minimum Education :
Minimum Experience / Training Required :
Skills Required
regulatory audits
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India • Mumbai, India