Sr Computer System Validation Analyst

Diensten Tech; Hyderabad, Bengaluru; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Diensten Tech Ltd. seeks an experienced CSV Consultant to validate pharmaceutical IT systems across GMP environments in India. The role emphasizes GxP compliance, regulatory alignment (GAMP 5, 21 CFR Part 11, EU Annex 11) and rigorous documentation.

You will perform gap analyses, retrospective validation, and coordinate with QA, IT, and manufacturing teams. The ideal candidate has 2–8 years of CSV experience, strong data integrity knowledge (ALCOA+), and hands-on validation experience with PLC,

Qualifications

• 2–8 years of CSV experience in pharma/Life Sciences.
• Experience with GxP, 21 CFR Part 11, EU Annex 11.
• Ability to prepare validation docs like IQ/OQ/PQ, URS, FRS, RTM.
• Experience validating PLC/SCADA/HMI systems.
• Knowledge of ALCOA+ data integrity.

Responsibilities

• Execute CSV activities for GxP computerized systems per regulatory requirements.
• Conduct Gap Assessments/Gap Analysis to identify compliance gaps.
• Perform retrospective validation and compliance assessments for existing systems.
• Prepare/review Validation Plans, URS/FRS, Risk Assessments, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Ensure adherence to GAMP 5, 21 CFR Part 11, EU Annex 11; maintain data integrity.
• Carry out system/risk/data integrity assessments; support change control and CAPA.
• Review test scripts, execution evidence, deviations, and validation deliverables.
• Collaborate with QA, IT, engineering, manufacturing, and QC for regulatory compliance.
• Support audits with inspection-ready validation documentation and GDP compliance.

Skills

CSV (Computer System Validation)

Pharmaceutical / Life Sciences

Gap Assessment & Gap Analysis

Retrospective Validation

GxP Compliance

GAMP 5

21 CFR Part 11 & EU Annex 11

Data Integrity / ALCOA+

IQ/OQ/PQ & Risk Assessment

Validation Documentation & RTM

PLC/SCADA/HMI exposure

Tools

PLC

SCADA

HMI

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