Hiring Alert Computer System Validation (CSV) Engineer
Position: Computer System Validation (CSV) Engineer
Experience: 2-5 Years
Locations: Pune, Nashik, Pithampur, Goa, Nagpur
Key Responsibilities:
- Validate QC systems, manufacturing systems, and software applications.
- Execute Computer System Validation (CSV) activities throughout the validation lifecycle.
- Prepare and review URS, Validation Plans, IQ, OQ, PQ protocols, reports, and related documentation.
- Perform risk assessments and ensure compliance with regulatory requirements.
- Ensure compliance with 21 CFR Part 11, GAMP guidelines, and the V-Model approach.
- Coordinate with cross-functional teams to support validation and audit readiness.
Required Skills:
- Hands-on experience in QC Systems/Software Validation
- Manufacturing (MFG) Systems Validation
- 21 CFR Part 11 Compliance
- GAMP Categories
- V-Model Methodology
- Validation Lifecycle Management
- IQ, OQ & PQ Execution
- Risk Assessment
- URS Preparation & Validation Documentation
Qualification: BE/B.Tech/M.Tech/B.Pharm/M.Pharm or equivalent (preferred)
Interested candidates can share their updated resume with their current CTC, expected CTC, notice period, and preferred location.
Interested candidates can apply at:
[email protected] / [email protected] or 9109188709/ 9109188512/ 9109188252
Pay: From ₹500,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Work Location: In person
