GxP CSV Validation Engineer I 6 to 14 Years I Hyderabad I
Capgemini
2 - 5 years
Hyderabad
Posted: 28/03/2025
Job Description
Job Description
The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11).They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation.
Primary Skill
s Bachelor’s or Master’s degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related fieldCertifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous
Skills (competencies)
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fuelled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.
About Company
Capgemini is a global leader in consulting, technology services, and digital transformation. Headquartered in Paris, France, Capgemini provides a wide range of services, including IT consulting, managed services, business process outsourcing, and digital transformation solutions. With over 360,000 employees across more than 50 countries, the company focuses on helping organizations innovate and transform their businesses to remain competitive in a rapidly changing digital landscape. Capgemini is known for its expertise in cloud computing, AI, cybersecurity, and other emerging technologies, working closely with clients to develop sustainable and cutting-edge solutions.
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