Validation officer-QA
3 days ago
Perform and oversee Cleaning Validation activities for manufacturing and packaging equipment as per approved protocols.
We are seeking a Cleaning & Validation Specialist for our Injectables Sterile Parenteral Plant . The role involves execution and review of cleaning validation, equipment validation, and utility qualification activities to ensure compliance with global regulatory standards.
- Designation: QA/Validation Specialist- Cleaning & Validation
Key Responsibilities
- Mostly: Cleaning Validation
- Execute and review equipment validation including:
- Autoclaves (moist heat sterilizers)
- BFS (Blow-Fill-Seal) machine validation
- Superheated water autoclaves
- Conduct Water System Validation (Purified Water, WFI, Clean Steam) and associated storage & distribution tanks.
- Ensure proper execution of calibration activities for critical instruments and utilities.
- Prepare, review, and approve validation protocols, reports, and SOPs in compliance with cGMP and regulatory expectations.
- Support preparation and execution of Validation Master Plan (VMP).
- Ensure validation activities are aligned with site Quality Management System (QMS).
- Participate in regulatory and customer audits; provide validation data, reports, and justifications.
- Ensure timely re qualification and periodic validation as per site schedule.
- Train and guide plant personnel on cleaning and validation practices.
- Equipment and Instruments:
- Qualification and Validation with calibration activity of Equipment and Instruments.
- Super Heated Autoclave, HPHV autoclave, HVAC Systems, BFS filling machine, Compressed air, Pure Steam, Water System, LAF, RLF, Tanks calibration activity .
Qualifications & Experience
- Education: B.Pharm / M.Pharm / M.Sc (Microbiology, Biotechnology, Chemistry).
- Experience: 3–5 years in Validation function within a Injectables Sterile Parenteral .
- Full-time, On-site (Patas, Pune)
Job Type: Full-time
Pay: ₹25, ₹40,000.00 per month
Benefits:
- Provident Fund
Work Location: In person
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