Job Description
Job Description
Key Responsibilities:-
Form, mentor, and develop the Manufacturing QMS team (Executives/Senior Executives)- Establish document governance for SOPs/WIs/BMRs and ensure timely revisions and harmonization- Lead Manufacturing Change Control governance and alignment with QA/CCB- Chair weekly QMS review meetings and publish site-wide QMS dashboards- Ensure audit/inspection readiness; lead responses to regulatory/customer observations- Drive CAPA effectiveness, deviation reduction initiatives, and trend reviews- Champion eQMS improvements, digitization projects, and training effectiveness programs
Technical / Functional Skills:- Deep knowledge of cGMP, Annex 1, ICH Q9/Q10, and data integrity (ALCOA+)- Hands-on experience with enterprise eQMS platforms (TrackWise, MasterControl, or equivalent)- Experience managing change controls, deviations, investigations, and CAPA at scale- Strong understanding of documentation lifecycle management and regulatory expectations
Behavioral Competencies:- Strategic leadership with strong cross-functional influence- Mentoring, coaching, and capability-building mindset- Decision-making based on risk-based and data-driven principles
Qualifications
Experience: 1418 Years (Sterile Injectables) Qualification: B.Pharm / M.Pharm (Advanced degree preferred)
