QA Manager (Pharmaceutical Manufacturing)

Job Description

We are hiring a QA Manager to lead Quality Assurance activities at our manufacturing facility. The role will ensure strong GMP compliance, robust documentation, smooth batch release, and audit readiness for regulatory and customer inspections.

Key Responsibilities

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  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/approve SOPs, BMR/BPR, formats, protocols, logbooks; ensure strong GDP and data integrity.

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  Batch Release: Oversee batch record review and timely product release as per specifications and timelines.

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  IPQA Oversight: Guide IPQA activities—line clearance, in-process checks, deviations, change control and documentation discipline.

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  Investigations: Lead deviations, OOS/OOT, complaints, root-cause analysis and CAPA closure with effectiveness checks.

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  Change Control & Risk Management: Manage change controls, impact assessments and risk-based decisions.

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  Validation & Qualification Support: Coordinate IQ/OQ/PQ, process validation, cleaning validation, utilities qualification and periodic reviews.

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  Audits & Inspections: Handle WHO/customer audits, vendor audits, internal audits; ensure closure of observations on time.

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  Training & Team Management: Train and develop QA/IPQA team; run GMP trainings and ensure skill compliance.

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  Quality Metrics: Track QA KPIs (right-first-time, deviation trend, CAPA ageing, audit scores) and drive improvements.

Requirements

Requirements

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  Experience: 6–10 years in QA in pharmaceutical manufacturing, with 2+ years in a managerial/lead role.

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  Education: B.Pharm / M.Pharm (preferred) or M.Sc (relevant).

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  Strong Knowledge: WHO-GMP, Schedule M, GDP, data integrity, CAPA, deviations, change control, validation basics.

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  Skills: Leadership, audit handling, documentation excellence, problem-solving, strong coordination with cross-functional teams.

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  Tools: MS Office, ERP/LIMS exposure preferred.

Benefits

Benefits

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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