Job Title: IT CSV (Computer System Validation) Specialist
Location: Mumbai (Work from Office)
Experience: 2–5 Years
Employment Type: Full-Time
Joining Preference: Immediate Joiners Preferred
Job Summary
We are seeking an IT CSV (Computer System Validation) Specialist with 2–5 years of experience in validating Gx P-regulated computerized systems within pharmaceutical, biotechnology, medical device, or life sciences environments. The candidate will be responsible for ensuring compliance with regulatory requirements, supporting validation activities, and maintaining validated systems throughout their lifecycle.
Key Responsibilities
Execute Computer System Validation (CSV) activities for Gx P-regulated applications and infrastructure.
Develop and review validation deliverables including Validation Plans, Risk Assessments, URS, FS, DS, IQ, OQ, PQ, Traceability Matrix, and Validation Summary Reports.
Support system implementation, upgrades, migrations, and periodic reviews.
Conduct risk-based validation in compliance with GAMP 5 guidelines.
Collaborate with Quality, IT, Business,



and Vendor teams throughout the validation lifecycle.
Support audit and inspection readiness activities.
Ensure compliance with 21 CFR Part 11, Annex 11, Gx P, Data Integrity, and ALCOA+ principles.
Assist in deviation management, CAPA implementation, and change control activities.
Maintain validation documentation and ensure systems remain in a validated state.
Required Qualifications
Bachelor's degree in Computer Science, Information Technology, Life Sciences, Pharmacy, Biotechnology, or related field.
2–5 years of hands-on experience in Computer System Validation within a regulated workplace.
Strong understanding of GAMP 5, Gx P, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Experience preparing and executing IQ/OQ/PQ protocols.
Knowledge of SDLC and validation lifecycle methodologies.
Strong documentation, communication, and stakeholder management skills.
Preferred Skills
Exper

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