We are hiring a QA Manager to lead Quality Assurance at our manufacturing facility. The role ensures strong GMP compliance, solid documentation, timely batch release, and full audit readiness for regulatory and customer inspections.
Key Responsibilities
GMP Compliance: Ensure day-to-day compliance with WHO-GMP, Schedule M, and internal quality systems across Production, QC, Warehouse, and Utilities.
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Documentation Control: Review and approve SOPs, BMR/BPR, protocols, formats, and logbooks; maintain strong GDP and data integrity.
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Batch Release: Oversee batch record review and ensure timely product release as per specifications.
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IPQA Oversight: Guide IPQA activities — line clearance, in-process checks, deviations, and documentation discipline.
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Investigations: Lead deviations, OOS/OOT, market complaints, root-cause analysis, and CAPA closure with effectiveness checks.
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Change Control & Risk Management: Handle change controls, impact assessments, and risk-based decisions.
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Validation & Qualification: Coordinate IQ/OQ/PQ, process validation, cleaning validation, and utilities qualification.
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Audits & Inspections: Face WHO/customer audits, conduct vendor and internal/self-inspection audits, and ensure timely closure of observations.
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Team Management: Train, guide, and develop the QA/IPQA team; run regular GMP trainings.
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Quality Metrics: Track QA KPIs (right-first-time, deviation trend, CAPA ageing, audit scores) and drive improvements.
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Experience: Minimum 8 years in pharmaceutical QA, with at least 4 years as a QA Manager / lead.
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Education: B.Pharm / M.Pharm (preferred) or M.Sc (relevant field).
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Strong Knowledge: WHO-GMP, Schedule M, GDP, data integrity, CAPA, deviations, change control, and validation.
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Skills: Leadership, audit handling, documentation excellence, problem-solving, and strong cross-functional coordination.
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Tools: MS Office; ERP/LIMS exposure preferred.
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Traits: Detail-oriented, disciplined, accountable, and confident in facing audits.
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Competitive CTC + performance bonus
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Health & accidental insurance (self & family), PF/ESIC as per norms
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Professional training and growth opportunities
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Subsidised meals & company transport
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Stable, quality-driven work culture
