Senior QA Executive

6 days ago


Bhavnagar, 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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