DGM - QMS Lead role for a Sterile Injectables facility - Near Bharuch

About the Job

Job Description

Job Title: DGM - QMS Lead role for a Sterile Injectables facility - Near Bharuch


We are currently hiring for a Manufacturing DGM - QMS Lead role for a Sterile Injectables facility facility, requiring 14–18 years of experience, with a strong background in cGMP and quality systems.

🔹 Key Responsibilities:
Managed and develop the Manufacturing QMS team (Executives/Sr. Executives)
Establish and govern documentation systems (SOPs, WIs, BMRs)
Drive Change Control processes in alignment with QA/CCB
Chair QMS review meetings and publish dashboards
Ensure audit & inspection readiness and handle regulatory responses
Drive CAPA effectiveness, deviation reduction, and trend analysis
Lead eQMS improvements, digitization, and training programs
🔹 Technical Expertise:
Strong knowledge of cGMP, Annex 1, ICH Q9/Q10, and ALCOA+ (Data Integrity)
Hands-on experience with eQMS platforms (TrackWise, MasterControl, etc.)
Expertise in deviations, investigations, CAPA, and change control systems
Strong understanding of documentation lifecycle & regulatory expectations
🔹 Profile Requirements:
Experience: 15+ years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (preferred)


If this opportunity aligns with your experience or you have any suitable references, please feel free to share your profile.

Key Skills Required

Experience: 15+ years (Sterile Injectables)

Educational Requirements

B.Pharm / M.Pharm (preferred)