Computer System Validation (CSV) Consultant
Salary
Up to 1500000 INR (period unspecified) (amount units unconfirmed)
Experience
2-8 Years
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Job Description – 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 Good Documentation Practices (GDP) and applicable pharmaceutical quality standards.
Required Skills
- Computer System Validation (CSV)
- Pharmaceutical / Life Sciences experience
- Gap Assessment and Gap Analysis
- Retrospective Validation
- GxP Compliance (GMP/GLP/GCP)
- GAMP 5
- 21 CFR Part 11 and EU Annex 11
- Data Integrity and ALCOA+
- IQ/OQ/PQ and Risk Assessment
- Validation Documentation and RTM
- PLC, SCADA, HMI, laboratory or manufacturing systems exposure
- Audit Readiness, Change Control, and CAPA
Screening Questions
- How many years of experience do you have in Computer System Validation (CSV)?
- Have you performed Gap Assessments or Gap Analysis for GxP computerized systems?
- Do you have experience in retrospective validation?
- Have you worked with PLC, SCADA, HMI, laboratory, or manufacturing systems?
- Are you familiar with GAMP 5, 21 CFR Part 11, and EU Annex 11?
- Do you have hands-on experience preparing and reviewing IQ/OQ/PQ protocols and validation documents?
- Are you available to join immediately?
- Are you comfortable working in Bangalore or Indore?
Preferred candidates: Immediate joiners with pharmaceutical CSV experience and hands-on exposure to gap assessments, laboratory systems, and manufacturing systems.
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