Abbott - Head - TPM Quality Assurance - Biosimilars

Description:

Primary Job Function: TPMs supplying to Biosimilars in India and APAC region

- Quality Oversight of TPMs

- QMS Management at TPMs

- Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility

- Investigations of Products failures, OOS, Complaints pertaining to Abbott products

- Review of APQRs

- 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 TPMs 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 TPMs 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 Abbotts 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