02 Oct
|
Umendra Life Sciences
|
Odhav
02 Oct
Umendra Life Sciences
Odhav
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 solid 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, Valuable 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 investigations,
📌 Quality Assurance Manager Odhav
🏢 Umendra Life Sciences
📍 Odhav