Assistant Manager - Qualification & Validation (OSD)

Acme Formulation · India

Key Responsibilities

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

Qualification

• B.Pharm / M.Pharm / M.Sc.

Experience

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

Required Skills

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