We are hiring an experienced QA Manager to lead the Quality Assurance and compliance function at our WHO-GMP certified pharmaceutical manufacturing plant. The role is responsible for driving total GMP compliance, overseeing documentation systems, managing batch release, and maintaining continuous audit readiness for regulatory and customer inspections.
Key Responsibilities
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GMP Compliance: Ensure complete site-wide compliance with WHO-GMP, Schedule M, and cGMP guidelines across Production, QC, Warehouse, and Engineering.
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Quality Systems & Documentation: Review and approve SOPs, BMR/BPR, protocols, and logbooks while ensuring strict adherence to GDP and data integrity (ALCOA+).
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Batch Release: Oversee the end-to-end review of executed batch records and facilitate timely, compliant batch release and product release.
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IPQA Oversight: Supervise all IPQA functions including line clearance, sampling, in-process quality checks, and real-time shop floor compliance.
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Deviations & CAPA: Lead investigations for deviations, OOS/OOT, and market complaints using root-cause analysis tools; ensure effective CAPA implementation and closure.
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Change Control & Risk Management: Manage site change control systems, perform risk assessments, and evaluate impact across manufacturing processes and equipment.
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Validation & Qualification: Lead and review IQ/OQ/PQ, process validation, cleaning validation, and utilities qualification protocols and reports.
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Audits & Self-Inspection: Face customer and regulatory audits, manage internal self-inspection schedules, conduct vendor audits, and track observation compliance.
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Team Leadership: Lead, train, and mentor the QA and IPQA teams; conduct periodic cGMP and data integrity training programs for plant staff.
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Quality Metrics & MIS: Track key quality metrics, deviation trends, and CAPA ageing; present MIS reports to senior leadership and drive continuous quality improvement.
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Experience: Minimum 10+ years of experience in pharmaceutical Quality Assurance, with at least 3-5 years in a managerial or leadership capacity within a solid or liquid oral dosage manufacturing facility.
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Education: B.Pharm / M.Pharm or M.Sc in Chemistry/Life Sciences.
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Skills:
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Deep operational expertise in WHO-GMP, Schedule M, and GDP standards
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Strong track record in handling deviations, OOS/OOT, root-cause analysis, and CAPA
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Hands-on experience managing regulatory audits and customer inspections
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Thorough knowledge of process validation, cleaning validation, and equipment qualification
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Excellent team management, cross-functional coordination, and technical writing skills
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Personal Traits:
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Strong leadership, accountability, and decision-making capabilities
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High attention to detail with zero tolerance for compliance lapses
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Confident and articulate communicator during regulatory audits
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Competitive CTC + performance bonus
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Health & accidental insurance (self & family)
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PF / ESIC as per norms
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Subsidised meals & company transport
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Stable, quality-driven work culture
