Job DescriptionRole Overview

NTo provide strategic and operational leadership to the Quality Assurance function, ensuring that all MDI, Foam and OSD manufacturing activities comply with current GMP, regulatory requirements, and company quality standards. The role is responsible for building a culture of quality, driving compliance excellence, inspection readiness, and continuous improvement while enabling business growth.

NResponsibilities:

NQuality Management System

N

n Lead and continuously improve the Site Quality Management System (QMS). N Ensure compliance with global regulatory requirements including cGMP, ICH, WHO, EU GMP, US FDA, MHRA, PIC/S and other applicable regulations. N Ensure robust implementation of SOPs, quality policies and quality metrics. N Review periodic qualitytrends and drive improvements. NnManufacturing Quality Assurance

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n Provide QA oversight for MDI, Foam and OSD manufacturing operations. N Ensure compliance during dispensing, manufacturing, filling, packing and batch release activities. N Monitor critical process controls unique to inhalation products. N Drive right-first-time manufacturing through proactive quality oversight. NnValidation &

- Qualification

N

n Oversee process validation, cleaning validation, equipment qualification and computerized system validation. N Ensure lifecycle management of validation activities. NnDocumentation &

- Batch Release

N

n Review and approve Batch Manufacturing Records and Batch Packaging Records. N Ensure timely disposition of commercial and validation batches. N Approve quality documents, protocols and reports. NnInvestigations &

- CAPA

N

n Lead investigations related to deviations, OOS, OOT, complaints and product quality issues. N Ensure scientifically sound root cause analysis and effective CAPA implementation. N Monitor CAPA effectiveness and recurring trends. NnChange Control &

- Risk Management

N

n Chair Site ChangeControl Review Board. N Ensure quality risk assessments are performed for all significant changes.



N Drive Quality Risk Management principles across operations. NnRegulatory Compliance

N

n Maintain perpetual inspection readiness. N Lead health authority and customer audits. N Respond effectively to regulatory observations and ensure timely closure. NnSupplier &

- Material Quality

N

n Oversee supplier qualification and quality agreements. N Ensure incoming material quality systems are robust. N Support vendor audits and supplier quality improvement. NnProduct Quality Review

N

n Ensure Annual Product Quality Reviews (APQR/PQR) are completed. N Review quality trends and recommend improvement initiatives. NnPeople Leadership

N

n Lead, coach and develop the QA organization. N Build robust successionplanning and capability development. N Foster a culture of accountability, quality ownership and continuous learning. NnContinuous Improvement

N

n Drive digitalization and simplification of QA processes. N Improve quality metricssuch as: N Right First Time (RFT) N Deviation closure timelines N CAPA effectivenessn Batch release turnaround time N Audit observationsn Customer complaints NnCross-functional Collaboration

NPartner closely with:

N

n Manufacturing N Quality Controln Engineering N Technical Servicesn Supply Chain N Regulatory Affairsn Corporate Quality N EHSnnEducational Qualifications

N

n Masters / Bachelor's degree in Pharmacy, Pharmaceutical Science N Additional certification in Quality Management or regulatory affairs are desirable NnExperience

n

N 15–20 years in pharmaceutical quality functions. N Minimum 5 years in a leadership role managing QA teams. N Hands-on experience in MDI and DPI formulation manufacturing is essential. NnKnowledge and Skills (Functional / Technical)

N

n Experience handling regulatory inspections by agencies such as US FDA, MHRA, EMA, ANVISA, TGA, WHO, or other global authorities. N Experience in technology transfer, validation and commercial manufacturing of inhalation products. N Deep understanding of: N cGMPn Data Integrity N Risk Management (ICH Q9) N Pharmaceutical Quality System (ICH Q10) N

📌 Head Of Quality Assurance (India)
🏢 Glenmark Pharmaceuticals
📍 India