Manual QA Tester

4 hours ago

madhya pradesh, India Aligned Automation Services Full time

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

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