Quality Assurance Manager

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 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