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 timelines
CAPA effectiveness
Batch release turnaround time
Audit observations
Customer complaints

Cross-functional Collaboration
Partner closely with:
Manufacturing
Quality Control
Engineering
Technical Services
Supply Chain
Regulatory Affairs
Corporate Quality
EHS

Educational Qualifications
Masters / Bachelor’s degree in Pharmacy, Pharmaceutical Science
Additional 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:
cGMP
Data Integrity
Risk Management (ICH Q9)
Pharmaceutical Quality System (ICH Q10)
Process Validation
Cleaning Validation
Aseptic and contamination control principles where applicable
Strong understanding of inhalation device quality requirements and product lifecycle management.
Knowledge of computerized quality systems and electronic documentation

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