Manager : Quality Assurance
Hyderabad · Full Time
Manager : Quality Assurance Role Overview Clintask Solutions is looking for a QA Manager with hands-on experience in GxP Quality Assurance, GCP/GLP/GPV/GMP audits, QMS management and Computer System Validation (CSV/CSA). Key Responsibilities Conduct and manage GCP/GLP, vendor and computerised system audits. Manage QMS activities, including SOPs, document control, CAPA, deviations, change control and training. Execute and manage CSV/CSA activities for enterprise and GxP systems such as eQMS, EDC, CTMS and ERP. Prepare and review validation documentation, including risk assessments, test protocols, traceability matrices and validation reports. Ensure compliance with applicable GxP regulations, 21 CFR Part 11, EU Annex 11 and GAMP 5. Support client engagements, audit readiness and quality/compliance consulting projects. Required Qualifications #Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Chemistry or a related scientific discipline. #6–10 years of relevant QA, GxP compliance and/or CSV experience. #Hands-on expertise in GCP/GLP audits, QMS, CAPA and document management. #Practical experience executing CSV/CSA for enterprise or regulated systems. Strong regulatory knowledge, documentation and communication skills. Interested candidates: Send your CV to hr@clintask.com.
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