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

📌 Assistant Manager – Qualification & Validation (OSD) (Baddi)
🏢 Acme Formulation
📍 Baddi