Senior QA Executive

1 week ago


New Delhi, India Adrta Technologies Private Limited Full time

TheSenior QA Executive / Senior QA Associateensures that the company’s pharma software products meetGxP ,21 CFR Part 11 ,Annex 11 ,GAMP 5 , and overall industry QA standards. This role acts as a key bridge between software development teams and pharma quality teams to ensure the product is compliant, validated, and audit-ready. Key ResponsibilitiesReview and test software features for pharma regulatory compliance ( GMP, GxP, 21 CFR Part 11 ). Support complete software validation lifecycle ( IQ/OQ/PQ documentation, validation protocols, risk assessments ). Review, prepare, and maintainSOPs, user manuals, validation documents , and other quality-related documentation. Work closely with pharma clients to understand quality workflows and map them to the software. Participate in internal, external, and client audits for software quality and compliance. Coordinate with development and internal QA teams to ensure high-quality, compliant, bug-free releases. Maintain complete traceability usingURS → FRS → Design → Test Cases → Validation Reportsmapping. Support implementation teams in client discussions related topharma quality processes and compliance . Skills RequiredStrong understanding ofPharma QA processes(Deviations, CAPA, Change Control, Audit Trail, Data Integrity). Knowledge ofQMS, LIMS, LMS, or Document Management Systems . In-depth knowledge of regulatory guidelines ( 21 CFR Part 11, Annex 11, GAMP 5 ). Experience insoftware testing, CSV (Computer System Validation), and documentation . Excellent communication skills for client coordination and audit discussions. Experience RequiredMinimum 5 years of relevant experiencein Pharma QA or Pharma Software QA/Validation. Salary Range₹10,00,000 to ₹16,00,000 per annum (10–16 LPA) (Based on experience and interview performance)


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