Job DescriptionKey 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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nQualification

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- B.Pharm / M.Pharm / M.Sc.
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nExperience

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- 8-12 years of Qualification & Validation experience in a regulated OSD pharmaceutical manufacturing facility.
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nRequired 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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📌 Assistant Manager - Qualification & Validation (India)
🏢 Acme Formulation
📍 India