Job DescriptionUmendra Life Sciences is looking for an experienced Head – Quality Assurance to lead the Quality Assurance function at our pharmaceutical manufacturing facility in Bavla, Ahmedabad. This is a site-level leadership position with responsibility for the effectiveness of the Quality Management System, manufacturing compliance, inspection readiness, audit management and overall QA governance. We are looking for a quality professional who can combine strong regulatory understanding with hands-on operational control and build a robust quality culture across the facility. Key Responsibilities • Lead the complete Quality Assurance function for the manufacturing site • Own and continuously strengthen the site's Quality Management System (QMS) • Ensure compliance with cGMP, data integrity, Positive Documentation Practices and applicable regulatory requirements • Provide QA oversight across manufacturing, packing, warehouse, engineering and other GMP operations • Lead governance of deviations, CAPA, change controls, investigations,



risk assessments and effectiveness checks • Ensure investigations demonstrate sound root-cause analysis and result in sustainable corrective and preventive actions • Oversee IPQA and shop-floor quality systems , including line clearance, dispensing, manufacturing and packing controls • Ensure appropriate review and approval of BMRs/BPRs, SOPs, protocols, specifications and controlled quality documentation • Lead and coordinate regulatory inspections, customer audits, internal audits and vendor audits • Own audit observation responses, CAPA commitments and timely closure of regulatory/customer observations • Maintain continuous inspection readiness across departments • Provide QA leadership for process validation, cleaning validation, equipment qualification, computerized systems and other validation activities • Review recurring deviations, complaints, failures and quality trends to identify systemic weaknesses • Participate in OOS/OOT inv

📌 Quality Assurance Manager (Gujarat)
🏢 Umendra Life Sciences
📍 Gujarat