Role & responsibilities

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.

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