Job Description
Manager / Senior Manager – Quality Assurance (Vendor Qualification & Supplier Quality Management)

Department - Quality Assurance (Corporate QA)

Location - Vapi, Gujarat

Qualification
- M.Pharm / M.Tech / M.Sc. (Pharmaceutical Sciences or Life Sciences)
- Candidates from the pharmaceutical industry will be preferred.

Experience
- 10–15 years of relevant experience in Quality Assurance with extensive expertise in Vendor Qualification, Supplier Quality Management, GMP Audits, and Quality Systems within a regulated pharmaceutical manufacturing setting.

Key Responsibilities:
- Prepare, review, revise, and periodically update SOPs, formats, templates, checklists, questionnaires, related to vendor qualification, supplier management, and outsourced activities in compliance with applicable GMP and regulatory requirements.
- Establish and maintain a risk-based supplier qualification program for raw materials, starting materials, ancillary materials, packaging materials, consumables, critical reagents, and service providers.




- Perform supplier qualification and periodic requalification through desktop assessments, remote audits, on-site audits, quality questionnaires, and evaluation of regulatory inspection history and quality performance.
- Qualify and monitor outsourced service providers, including contract testing laboratories, contract manufacturing organizations (CMOs), calibration agencies, validation service providers, logistics providers, warehouses, and other GxP service providers.
- Conduct supplier risk assessments considering material criticality, regulatory compliance history, quality performance, business continuity, and supply chain risks to determine the appropriate qualification approach.
- Develop annual vendor audit plans based on quality risk management principles and organizational priorities.
- Prepare audit plans, agendas, questionnaires, and checklists for supplier and outsourced activity audits.
- Perform desktop, remote, and o

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