Head of Quality Assurance(TPM- Biosimilars)

Right Advisors Private Limited; Mumbai; Vor Ort; INR 1.500.000 - 2.500.000; Vollzeit

Zusammenfassung

A leading pharmaceutical firm is seeking a Head of Quality Assurance in Mumbai to oversee quality operations and ensure compliance at TPMs. The ideal candidate will have a relevant advanced degree and a minimum of 12 years of experience in a quality function, preferably in biosimilars. This full-time role requires a proactive approach to quality oversight and regulatory compliance.

Qualifikationen

• Minimum 12 years of experience in quality function.
• Experience in a biosimilar site is beneficial.
• Understanding of Abbott policies and procedures.

Aufgaben

• Oversee quality operations across TPM’s.
• Lead quality strategy implementation at TPM sites.
• Ensure compliance with regulatory standards.

Kenntnisse

Quality Oversight

Regulatory compliance

GMP compliance

Investigation of product failures

Training and awareness programs

Ausbildung

M Pharm, M.Sc Biochemistry, Microbiology or equivalent

Jobbeschreibung

Head of Quality Assurance (TPM‑Biosimilars)

Primary Job Function: TPM’s supplying to Biosimilars in India and APAC region

• Quality Oversight of TPM’s
• Inspection readiness for Abbott audits and Regulatory audits for sites under responsibility
• Investigations of Product 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 a 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 an important management tool with increased visibility across the business and guide the team for effective implementation at 3rd party contractors.
• Create a 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.

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.
• 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

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Quality Assurance
• Pharmaceutical Manufacturing and Medical Equipment Manufacturing

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