Validation Officer-qa
21 hours 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)**
Pay: ₹25,000.00 - ₹40,000.00 per month
**Benefits**:
- Provident Fund
Work Location: In person
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