Quality Assurance Manager

Micro Crispr Pvt. Ltd. · Gujarat, India

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 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