Quality Assurance Manager

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, 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 investigations, product quality reviews and quality risk management activities

• Ensure appropriate oversight of training, document control and quality systems

• Work closely with Production, QC, Regulatory Affairs, Engineering, Warehouse and senior management to resolve quality and compliance risks

• Develop, mentor and manage the QA/IPQA team

• Establish clear quality metrics and regularly review departmental performance, compliance status and open quality actions

• Escalate significant quality or compliance risks to management and ensure appropriate corrective action

Candidate Profile

• B.Pharm / M.Pharm / M.Sc. or equivalent relevant pharmaceutical qualification

• Approximately 15+ years of pharmaceutical Quality Assurance experience , with meaningful experience in a leadership role

• Strong experience working in a regulated pharmaceutical manufacturing environment

• Demonstrated experience managing QMS, audits, investigations, CAPA, deviations, change control and validation systems

• Strong understanding of USFDA expectations and 21 CFR requirements is highly preferred

• Experience handling USFDA inspections or US-regulated customers will be a significant advantage

• Experience with creams, ointments, gels, lotions, topical OTC products or other external pharmaceutical formulations will be particularly relevant

• Should have strong exposure to both documentation systems and manufacturing-floor compliance

• Strong investigation, decision-making and cross-functional leadership capabilities

• Ability to challenge weak systems constructively and drive measurable quality improvement

What We Are Looking For

This role requires someone who can function as the quality leader of the site , not simply administer documentation.

The successful candidate should be capable of identifying compliance risks before they become audit observations, maintaining discipline across quality systems, driving timely closure of issues and ensuring that GMP requirements are consistently reflected in actual shop-floor practices.

This is a full-time, on-site leadership position at our Bavla manufacturing facility.