Job Summary
We are looking for a skilled Computer System Validation (CSV) Engineer to join our team. The ideal candidate will have hands-on experience in validating computerized systems within regulated environments, ensuring compliance with industry standards and regulatory requirements.
Key Responsibilities
· -Perform validation of QC laboratory systems, software, and computerized systems.
· -Execute the complete Computer System Validation (CSV) lifecycle, including planning, execution, and reporting.
· -Prepare and execute validation protocols such as IQ, OQ, and PQ.
· -Conduct equipment qualification activities and maintain associated documentation.
· -Ensure compliance with 21 CFR Part 11, GAMP, and applicable regulatory guidelines.
· -Develop and review CSV documentation, including Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments, ----Validation Protocols, Traceability Matrices, and Validation Summary Reports.
· -Coordinate with Quality Assurance, IT, Engineering, and end users during validation activities.
· -Support audits and inspections by providing validation documentation and compliance evidence.
Contact - [email protected] / 9109188512
Pay: ₹10,000.00 - ₹35,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund
Work Location: In person
