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 ope

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