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 environment.

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 in office GMP audits of su

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