01Role 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.
02Responsibilities
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 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 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 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 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 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 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 Leadership- Lead, coach and develop the QA Build strong 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 complaintsCross-functional CollaborationPartner closely with:- Manufacturing- Quality Control- Engineering- Technical Services- Supply Chain- Regulatory Affairs- Corporate Quality- EHSEducational Qualifications- Masters / Bachelors degree in Pharmacy, Pharmaceutical Science- Additional certification in Quality Management or regulatory affairs are desirableExperience- 1520 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- Robust understanding of inhalation device quality requirements and product lifecycle management.- Knowledge of computerized quality systems and electronic documentation .
