Gxp Csv Validation Engineer I 6 To 14 Years I Hyderabad I @ Capgemini

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Gxp Csv Validation Engineer I 6 To 14 Years I Hyderabad I

Capgemini
6 - 11 years
Hyderabad
18 days ago
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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)

Job Classification

Industry: IT Services & Consulting
Functional Area / Department: Engineering - Software & QA
Role Category: Quality Assurance and Testing
Role: Performance Testing Engineer
Employement Type: Full time

Contact Details:

Company: Capgemini
Location(s): Hyderabad

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Keyskills: 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

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Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Capgemini

Capgemini Invent

Gxp Csv Validation Engineer I 6 To 14 Years I Hyderabad I @ Capgemini

Home > Quality Assurance and Testing