01 Oct
|
Umendra Life Sciences
|
Odhav
01 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 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, 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