Job Description Key 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 n
n Qualification
n n B.Pharm / M.Pharm / M.Sc.
n n
n Experience
n n 8-12 years of Qualification & Validation experience in a regulated OSD pharmaceutical manufacturing facility.
n n
n Required 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 knowledge
n n

📌 Assistant Manager - Qualification & Validation (OSD) (Nalagarh)
🏢 Acme Formulation
📍 Nalagarh