Senior QA Executive

5 days ago


bangalore, India Adrta Technologies Private Limited Full time

The Senior QA Executive / Senior QA Associate ensures that the company’s pharma software products meet GxP , 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 Responsibilities Review 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 maintain SOPs, 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 using URS → FRS → Design → Test Cases → Validation Reports mapping. Support implementation teams in client discussions related to pharma quality processes and compliance . Skills Required Strong understanding of Pharma QA processes (Deviations, CAPA, Change Control, Audit Trail, Data Integrity). Knowledge of QMS, LIMS, LMS, or Document Management Systems . In-depth knowledge of regulatory guidelines (21 CFR Part 11, Annex 11, GAMP 5 ). Experience in software testing, CSV (Computer System Validation), and documentation . Excellent communication skills for client coordination and audit discussions. Experience Required Minimum 5 years of relevant experience in 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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