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 c GMP, 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 c GMP &
- Data Integrity

Change Control, CAPA &

- Risk Management

Regulatory Audit Handling

ERP/LIMS knowledge

📌 Assistant Manager – Qualification & Validation (osd) (Thane)
🏢 Acme Formulation
📍 Thane