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
Solid 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.
Valuable 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.

📌 Executive/sr Executive, Qms Injectable Manufacturing Ahmedabad (India)
🏢 Intas
📍 India