Role Overview:

To 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.

Responsibilities:

Quality Management System

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

Manufacturing Quality Assurance

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

Validation & Qualification

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

Documentation & Batch Release

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

Investigations & CAPA

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

Change Control & Risk Management

Chair Site Change Control Review Board.Ensure quality risk assessments are performed for all significant changes.Drive Quality Risk Management principles across operations.

Regulatory Compliance





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

Supplier & Material Quality

Oversee supplier qualification and quality agreements.Ensure incoming material quality systems are robust.Support vendor audits and supplier quality improvement.

Product Quality Review

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

People Leadership

Lead, coach and develop the QA organization.Build solid succession planning and capability development.Foster a culture of accountability, quality ownership and continuous learning.

Continuous Improvement

Drive digitalization and simplification of QA processes.Improve quality metrics such as:Right First Time (RFT)Deviation closure timelinesCAPA effectivenessBatch release turnaround timeAudit observationsCustomer complaints

Cross-functional Collaboration

Partner closely with:

ManufacturingQuality ControlEngineeringTechnical ServicesSupply ChainRegulatory AffairsCorporate QualityEHS

Educational Qualifications

Masters / Bachelor’s degree in Pharmacy, Pharmaceutical ScienceAdditional certification in Quality Management or regulatory affairs are desirable

Experience

15–20 years in pharmaceutical quality functions.Minimum 5 years in a leadership role managing QA teams.Hands-on experience in MDI and DPI formulation manufacturing is essential.

Knowledge and Skills (Functional / Technical)

Experience handling regulatory inspections by agencies such as US FDA, MHRA, EMA, ANVISA, TGA, WHO, or other global authorities.Experience in technology transfer, validation and commercial manufacturing of inhalation products.Deep understanding of:cGMPData IntegrityRisk Management (ICH Q9)Pharmaceutical Quality System (ICH Q10)Process ValidationCleaning ValidationAseptic and contamination control principles where applicableStrong understanding of inhalation device quality requirements and product lifecycle management.Knowledge of computerized quality systems and electronic documentation

📌 Head of Quality Assurance (Sambhajinagar)
🏢 Glenmark Pharmaceuticals
📍 Sambhajinagar