Job Description

Job Description

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

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Department - Quality Assurance (Corporate QA)

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Location - Vapi, Gujarat

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Qualification

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

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- 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.
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Key Responsibilities:

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1. 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.
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2. Establish and maintain a risk-based supplier qualification program for raw materials, starting materials,



ancillary materials, packaging materials, consumables, critical reagents, and service providers.
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3. Perform supplier qualification and periodic requalification through desktop assessments, remote audits, in office audits, quality questionnaires, and evaluation of regulatory inspection history and quality performance.
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4. 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.
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5. Conduct supplier risk assessments considering material criticality, regulatory compliance history, quality performance, business continuity, and supply chain risks to determine the appropriate qualification approach.
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6. Develop annual vendor audit plans based on quality risk management principles and organizational priorities.
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7. Prepare audit plan

📌 Quality Assurance Manager (Vapi)
🏢 Micro Crispr
📍 Vapi