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Capgemini
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GxP CSV Validation Engineer I 6 To 14 Years I Hyderabad I

GxP CSV Validation Engineer I 6 To 14 Years I Hyderabad I

Capgemini

6 - 11 years

7 - 12 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

pq csv gamp oq iq risk assessment data validation gmp change control sop qms 21 cfr computer system validation gxp production operation capa risk management fda equipment qualification usfda cfr medical devices quality assurance urs mdr

Work Mode

Work from Office

Job Type

Full Time

Job Description

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. 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 Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

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GxP CSV Validation Engineer I 6 To 14 Years I Hyderabad I