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.
- 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.

📌 Executive/Sr. Executive, QMS (Injectable Manufacturing) (Ahmedabad)
🏢 Intas
📍 Ahmedabad