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Capgemini
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GxP Manual Functional Tester

GxP Manual Functional Tester

Capgemini

3 - 6 years

Hyderabad

Posted:8 months ago

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Job Description

Your Role

We are seeking an experienced GxP Manual Functional Tester with strong knowledge of GxP compliance, CSV (Computer System Validation), and regulated system testing within the Life Sciences or Pharma domain. The tester will be responsible for validating business applications, documenting evidence, executing test cases, and ensuring compliance with regulatory standards.

Strong understanding of GxP (Good Practice) regulations including GMP, GCP, GLP.Experience working in FDAregulated environments (21 CFR Part 11, Annex 11).
Hands-on experience in:Computer System Validation (CSV), Validation documentation (URS, FRS, RTM, IQ/OQ/PQ, etc.)
Experience with endtoend functional testing of enterprise systems.Ability to design, execute, and document Test scenarios, Test cases, Test scripts
Detailed defect logging and root cause identification.

Your Profile

Knowledge of SDLC/STLC and best QA practices.
Understanding of Data Integrity principles (ALCOA / ALCOA+).
Familiarity with Life Sciences systems such as LIMS, MES, ERP, QMS, or clinical applications.
Exposure to API testing or basic SQL for backend validation (optional but beneficial).
Experience working in Agile, Waterfall, or hybrid delivery models.
Good communication skills for collaborating with business, validation, and compliance teams.

What you will love about working here

You can shape your with us. We offer a range of career paths and internal opportunities within Capgemini group. You will also get personalized career guidance from our leaders.
You will get comprehensive wellness benefits including health checks, telemedicine, insurance with top-ups, elder care, partner coverage or new parent support via flexible work.
At Capgemini, you can work on in tech and engineering with industry leaders or create to overcome societal and environmental challenges.

Skills Required

compliance insurance telemedicine erp csv enterprise systems cfr sql qa gcp waterfall design mes life sciences agile pharma sdlc api testing communication skills

Work Mode

Work from Office

Job Type

Full Time

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GxP Manual Functional Tester