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



technology transfer, and qualification documentation for regulatory submissions.n
- Conduct validation-related training and ensure documentation compliance.n

nQualification
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- B.Pharm / M.Pharm / M.Sc.n

nExperience
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- 8-12 years of Qualification & Validation experience in a regulated OSD pharmaceutical manufacturing facility.n

nRequired Skills
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- Equipment Qualification (DQ/IQ/OQ/PQ)n
- Process & Cleaning Validationn
- Validation Master Plan (VMP)n
- HVAC & Utility Qualificationn
- cGMP & Data Integrityn
- Change Control, CAPA & Risk Managementn
- Regulatory Audit Handlingn
- ERP/LIMS knowledgen

📌 Assistant Manager (Kaundi)
🏢 Acme Formulation
📍 Kaundi