Head TPM - QA (Biosimilars) Large Molecules - APAC & India Region (Diversity Candidates Only)

Qualification: M Pharm, M.Sc Biochemistry, Microbiology or equivalent

Experience: Min. 12 Years (08 Years in QA)

Travelling: 5-7 Days in a month

Location: West Side

Must have:

* Minimum 12 years of overall experience (8 years into QA)

* IC Role

* Quality Operations / Deviation Management with Biosimilars experience

* Networking Skills

* Travelling 25-30% in a Month (APAC-Region)

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

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.