Assistant Manager - Qualification & Validation (OSD)

Key Responsibilities

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• Execute and review Equipment Qualification (DQ/IQ/OQ/PQ) for manufacturing, packing, utilities, and laboratory equipment.
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• Plan, execute, and review Process Validation, Cleaning Validation, Hold Time Validation, and Revalidation activities.
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• Prepare and maintain Validation Master Plan (VMP), validation protocols, reports, and related SOPs.
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• Ensure timely qualification of facilities, utilities (HVAC, Water System, Compressed Air), and equipment.
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• Review validation-related deviations, change controls, CAPA, and risk assessments.
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• Ensure compliance with cGMP, data integrity, and regulatory requirements (USFDA, EU GMP, WHO GMP).
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• Support internal, customer, and regulatory audits.
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• Coordinate with Production, Engineering, QC, Warehouse, and Regulatory Affairs for validation activities.
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• Support APQR/PQR, technology transfer, and qualification documentation for regulatory submissions.
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• Conduct validation-related training and ensure documentation compliance.
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Qualification

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• B.Pharm / M.Pharm / M.Sc.
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Experience

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• 8-12 years of Qualification & Validation experience in a regulated OSD pharmaceutical manufacturing facility.
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Required Skills

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• Equipment Qualification (DQ/IQ/OQ/PQ)
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• Process & Cleaning Validation
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• Validation Master Plan (VMP)
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• HVAC & Utility Qualification
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• cGMP & Data Integrity
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• Change Control, CAPA & Risk Management
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• Regulatory Audit Handling
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• ERP/LIMS knowledge
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