Aligned Automation

2 weeks ago

Indore, India Aligned Automation Full time

Position : QA Tester Location : Indore, India Experience Required : 5+ yearsRole Overview :We are seeking an experienced QA Tester with a strong background in testing GxP/GMP-regulated computerized systems 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. This role involves ensuring that all computer system applications are thoroughly tested, documented, and validated to meet business, technical, and compliance requirements.Key Responsibilities :- Develop, 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 Qualifications :- Bachelors 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.Desired Skills and Experience : - QA Testing, Test plans, test cases, and test scripts for GMP-regulated computer systems and applications.- GxP, GMP, CSV (Computer System Validation) (ref:hirist.tech)

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