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

robust 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

O

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