Umendra 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 skilled 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, Good 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 in

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