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 Abbott 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