Manual Qa Tester

Job Description – QA Tester<\/b>
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<\/p> Position:<\/b> QA Tester<\/b>
<\/div> Location: <\/b>Indore, India
<\/div> Experience Required:<\/b> 5+ years
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Role Overview<\/b>
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We are seeking an experienced QA Tester<\/b> with a strong
background in testing GxP/GMP -regulated computerized systems<\/b> within the
pharmaceutical, biotech, or life sciences industry. The ideal candidate will
have hands -on experience in testing applications for compliance with regulatory
requirements such as 21 CFR Part 11, GAMP 5, and Annex 11<\/b>. This role
involves ensuring that all computer system applications are thoroughly tested,
documented, and validated to meet business, technical, and compliance
requirements.
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Key Responsibilities<\/b>
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• Develop,
  review, and execute test plans, test cases, and test scripts<\/b> for
  GMP -regulated computer systems and applications.
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• Ensure
  testing activities comply with GxP, GMP, CSV (Computer System
  Validation), and data integrity<\/b> requirements.
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• Collaborate
  with business analysts, developers, and validation teams to understand
  requirements and system design.
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• Perform functional, regression, integration, and user acceptance testing (UAT)<\/b> of applications.
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• Document
  and report defects in a structured manner and ensure timely resolution.
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• Support
  the preparation and review of validation deliverables<\/b> (e.g.,
  Requirements Traceability Matrix, Test Summary Reports).
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• Ensure
  adherence to SOPs, quality standards, and regulatory guidelines<\/b> throughout the testing lifecycle.
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• Participate
  in audits/inspections and provide evidence of testing and validation
  compliance.
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• Continuously
  identify opportunities for test process improvements<\/b> and automation
  where applicable.
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  Required Qualifications<\/b>
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  • Bachelor's
    degree in Computer Science, Information Technology, Life Sciences, or
    related field<\/b>.
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  • 5+
    years of experience<\/b> as a QA Tester in a regulated environment
    (pharmaceutical, biotech, or medical devices).
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  • Strong
    knowledge of GMP, GxP, CSV, 21 CFR Part 11, Annex 11, and GAMP 5
    guidelines<\/b>.
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  • Hands -on
    experience with test management tools<\/b> (e.g., HP ALM/QC, Jira,
    TestRail).
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  • Experience
    writing and executing detailed test scripts<\/b> with clear
    documentation.
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  • Strong
    understanding of Software Development Life Cycle (SDLC)<\/b> and System
    Development Life Cycle (SDLC) methodologies<\/b> (Agile, Waterfall,
    V -model).
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  • Excellent
    communication skills with ability to work in cross -functional teams.
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