Executive/Sr. Executive, QMS (Injectable Manufacturing)

Key Responsibilities :

• Manage and monitor QMS activities including Deviations, CAPA, Change Controls, OOS, OOT, Risk Assessments, and Market Complaints.
• Review, track, and ensure timely closure of deviations and CAPAs.
• Coordinate investigation activities related to quality events and support root cause analysis.
• Prepare and review SOPs, protocols, reports, quality manuals, and other GMP documentation.
• Support qualification, validation, and quality risk management activities.
• Ensure compliance with cGMP requirements, data integrity guidelines, and regulatory standards.
• Participate in internal audits, self-inspections, and regulatory/customer audits.
• Monitor QMS metrics and prepare periodic management review reports.
• Conduct GMP training programs and maintain training compliance records.
• Support regulatory inspections by USFDA, MHRA, EU GMP, WHO, TGA, and other agencies.
• Review and maintain documentation related to sterile manufacturing processes and aseptic practices.
• Coordinate with Production, QC, QA, Engineering, Warehouse, and Validation teams for quality compliance.

Educational Qualification

• B.Pharm / M.Pharm / M.Sc. (Microbiology, Biotechnology, Chemistry or relevant life science discipline)

Required Skills

• Strong knowledge of Injectable Quality Systems and cGMP requirements.
• Experience in Deviation, CAPA, Change Control, OOS/OOT handling.
• Understanding of Data Integrity (ALCOA+) principles.
• Familiarity with sterile manufacturing and aseptic processing requirements.
• Knowledge of USFDA, EU GMP, MHRA, WHO, and PIC/S guidelines.
• Good documentation and investigation skills.
• Proficiency in TrackWise, LMS, EDMS, or similar QMS software will be preferred.

Preferred Experience

• Experience in regulated pharmaceutical manufacturing facilities.
• Exposure to regulatory inspections and audit management.
• Experience in sterile injectable or parenteral manufacturing plants.