Computer System Validation (CSV) Consultant

NTT DATA Global Delivery Services Private Limited; Bengaluru; On-site; INR 900,000 - 1,600,000; Full time

Job summary

NTT DATA Global Delivery Services Private Limited is seeking an experienced CSV Consultant for Bangalore and Indore. The role focuses on validating GxP computerized systems, performing gap analyses, and ensuring data integrity across manufacturing, QC, and lab environments.

You will prepare validation plans, execution artifacts, and risk assessments, while maintaining compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11.

Qualifications

• Experience in Computer System Validation (CSV) within pharma IT compliance.
• Experience validating computerized systems used in pharmaceutical manufacturing, QA labs, or enterprise environments.
• Knowledge of GxP regulations and data integrity (ALCOA+).
• Hands-on with IQ/OQ/PQ protocols and validation documentation.

Responsibilities

• Execute CSV activities for GxP systems per regulatory requirements.
• Conduct Gap Assessments and Gap Analysis to identify compliance gaps.
• Perform retrospective validation and compliance assessments for existing systems.
• Prepare and review Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols, and VSRs.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Perform system risk, data integrity, and impact assessments.
• Validate laboratory and manufacturing systems including PLC, SCADA, and HMI where applicable.
• Review test scripts and validation deliverables; address deviations.
• Support change control, CAPA, and remediation of identified gaps.
• Collaborate with QA, IT, engineering, manufacturing, and QC teams for compliance.
• Support audits with inspection-ready documentation.
• Adhere to GDP and applicable pharmaceutical quality standards.

Skills

CSV

GxP compliance

Gap analysis

Retrospective validation

GAMP 5

21 CFR Part 11

EU Annex 11

Data integrity ALCOA+

IQ/OQ/PQ protocols

Validation documentation review

PLC/SCADA/HMI exposure

Audit readiness

Job description

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

1. Execute Computer System Validation (CSV) activities for GxP computerized systems in accordance with regulatory requirements.
2. Conduct Gap Assessments and Gap Analysis to identify compliance gaps against applicable regulatory standards and internal procedures.
3. Perform retrospective validation and compliance assessments for existing computerized systems.
4. Prepare and review validation documentation, including Validation Plans, URS, FRS, Risk Assessments, RTM, IQ/OQ/PQ protocols, and Validation Summary Reports.
5. Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles.
6. Perform system impact assessments, risk assessments, and data integrity assessments.
7. Validate laboratory and manufacturing systems, including relevant applications involving PLC, SCADA, and HMI, where applicable.
8. Review test scripts, test execution evidence, deviations, and validation deliverables.
9. Support change control, deviation management, CAPA, and remediation of identified compliance gaps.
10. Collaborate with QA, IT, engineering, manufacturing, and QC teams to ensure regulatory compliance.
11. Support internal and external audits by maintaining complete and inspection-ready validation documentation.
12. 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

1. How many years of experience do you have in Computer System Validation (CSV)?
2. Have you performed Gap Assessments or Gap Analysis for GxP computerized systems?
3. Do you have experience in retrospective validation?
4. Have you worked with PLC, SCADA, HMI, laboratory, or manufacturing systems?
5. Are you familiar with GAMP 5, 21 CFR Part 11, and EU Annex 11?
6. Do you have hands-on experience preparing and reviewing IQ/OQ/PQ protocols and validation documents?
7. Are you available to join immediately?
8. 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.