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, in office 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 on-site GMP audits of suppliers and outsourced facilities to assess compliance with applicable regulatory requirements and internal quality standards. # Prepare comprehensive audit reports, classify observations based on risk, communicate audit findings, and recommend supplier approval, conditional approval, or disqualification. # Review supplier responses, evaluate root cause analyses, monitor CAPA implementation, and verify the effectiveness and timely closure of audit observations. # Draft, review, implement, and periodically update quality technical agreements (QTAs) defining GMP responsibilities, quality oversight, change notification, deviation handling, documentation, testing responsibilities, and regulatory commitments. # Maintain and periodically update the approved vendor list (AVL) ensuring supplier qualification status, audit schedules, approval validity. # Participate in supplier-related investigations involving deviations, non-conforming materials, complaints, OOS results, and product quality issues, ensuring timely resolution and implementation of effective CAPAs. # Evaluate supplier-initiated changes, including manufacturing process changes, facility changes, material specification revisions, analytical method updates, and organizational changes through the change control process. # Coordinate with purchase, QC, manufacturing, warehouse, and other functions for supplier onboarding, qualification, approval, and ongoing performance monitoring. # Support regulatory inspections, customer audits, and internal audits by providing vendor qualification records, audit documentation, Quality Technical Agreements, and related quality documentation

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