Job DescriptionKey Responsibilities
N
- n
- 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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- N
- B.Pharm / M.Pharm / M.Sc. N

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

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

📌 Assistant Manager (India)
🏢 Acme Formulation
📍 India