Computer System Validation (CSV) Consultant

Diensten Tech Ltd.; Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Diensten Tech Ltd. is seeking an experienced Computer System Validation (CSV) Consultant for Bengaluru/Indore with immediate joining options.

The role involves leading CSV activities for GxP systems and coordinating with QA, IT, and manufacturing to ensure regulatory compliance. The ideal candidate will conduct Gap Assessments, retrospective validation, and deliver validation artifacts including IQ/OQ/PQ protocols, validation plans, risk assessments, and RTMs, while upholding GDP and ALCOA+ data

Qualifications

• Proven expertise in Computer System Validation within pharma/Life Sciences.
• Strong knowledge of GxP regulations and validation lifecycle activities.
• Experience with risk assessments, RTMs, IQ/OQ/PQ, and validation report documentation.
• Familiarity with GDP and data integrity (ALCOA+) principles.

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 on existing systems.
• Prepare and review validation documents (Validation Plans, URS, FRS, IQ/OQ/PQ, VSR, RTM).
• Ensure adherence to GDP and data integrity principles; support audits.

Skills

CSV

GxP Compliance

Gap Analysis

Retrospective Validation

GAMP 5

21 CFR Part 11

EU Annex 11

Data Integrity

IQ/OQ/PQ

Validation Documentation

PLC/SCADA/HMI

Audit Readiness

CAPA

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.