We are looking for an experienced Computer System Validation (CSV) professional with expertise in validating enterprise and digital systems within regulated environments. The candidate should possess strong knowledge of validation processes, compliance standards, and digital transformation programs.

Key Responsibilities
- Lead end-to-end Computer System Validation activities for enterprise applications and digital platforms.
- Prepare and review validation deliverables including URS, FS, DS, IQ, OQ, PQ, RTM, and validation reports.
- Ensure compliance with GxP, FDA, 21 CFR Part 11, and regulatory requirements.
- Coordinate with business, IT, quality assurance, and external vendors for validation activities.
- Support risk assessments, deviation handling, CAPA, and audit readiness.
- Validate systems related to manufacturing, supply chain, SAP ERP, and ICSM landscapes.
- Drive validation strategies for cloud-based and digital transformation initiatives.




- Provide governance and compliance support across validation projects.

Required Skills
- 10+ years of experience in Computer System Validation.
- Solid knowledge of GxP compliance and validation lifecycle methodologies.
- Experience with regulated environments in pharmaceutical, healthcare, or manufacturing industries.
- Hands-on experience in validation documentation and audit support.
- Strong stakeholder communication and project coordination skills.

Nice to Have
- Experience leading CSV activities for digital projects within Manufacturing and Supply Chain processes.
- Experience with SAP ERP or ICSM landscape validation projects.
- Exposure to cloud-based platforms and digital ecosystems.

Educational Qualification
- Bachelors degree in Engineering, Computer Science, Life Sciences, or related discipline.

📌 Computer System Validation (India)
🏢 Gemsource It Consulting
📍 India