– Computer System Validation (CSV) Consultant

Position: CSV Consultant Experience: 2–8 Years Locations: Bangalore & Indore Joining: Immediate Joiners Preferred Industry: Pharmaceutical / Life Sciences

Job Summary

We are looking for experienced Computer System Validation (CSV) Consultants with strong knowledge of pharmaceutical IT compliance, GxP regulations, validation lifecycle activities, and Gap Assessment / Gap Analysis. The ideal candidate should have experience validating computerized systems used in pharmaceutical manufacturing, quality control, laboratory, or enterprise environments.

Roles and Responsibilities

- Execute Computer System Validation (CSV) activities for GxP computerized systems in accordance with regulatory requirements.
- Conduct Gap Assessments and Gap Analysis to identify compliance gaps against applicable regulatory standards and internal procedures.
- Perform retrospective validation and compliance assessments for existing computerized systems.
- Prepare and review validation documentation, including Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols,



and Validation Summary Reports.
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
- Perform system impact assessments, risk assessments, and data integrity assessments.
- Validate laboratory and manufacturing systems, including relevant applications involving PLC, SCADA, and HMI, where applicable.
- Review test scripts, test execution evidence, deviations, and validation deliverables.
- Support change control, deviation management, CAPA, and remediation of identified compliance gaps.
- Collaborate with QA, IT, engineering, manufacturing, and QC teams to ensure regulatory compliance.
- Support internal and external audits by maintaining complete and inspection-ready validation documentation.
- Ensure adherence to Positive Documentation Practices (GDP) and applicable pharmaceutical quality standards.

Pay: ₹400,000.00 - ₹700,000.00 per year

Work Location: In person

📌 CSV (Indore)
🏢 Diensten Tech
📍 Indore