Deputy Manager or above - Production (Sterile Formulations)

Overview:

Responsible for managing sterile injectable production lines (vials, ampoules, PFS, Ophthalmic) with a focus on aseptic processing, GMP compliance, and team leadership. Ensures production meets quality, safety, efficiency, and regulatory standards.

Key Responsibilities:

• Lead daily production activities across all injectable lines (vials, ampoules, PFS,Ophthalmic), ensuring adherence to aseptic protocols and cGMP.
• Supervise and optimize batch yields, equipment utilization, and line efficiency (OEE).
• Review and approve Batch Manufacturing Records (BMRs), SOPs, and other documentation as per quality and regulatory standards.
• Ensure compliance with GMP, GDP, and international regulatory bodies such as USFDA, MHRA, EMA, and WHO.
• Allocate manpower and manage shift schedules to ensure smooth operations across all sterile areas.
• Provide training and mentorship to production staff on aseptic techniques, safety protocols, and quality practices, while coordinating with CFT to ensure timely qualification.
• Collaborate with cross-functional teams (QA, QC, Engineering, Validation) to address operational challenges, implement improvements, and ensure equipment is properly qualified and requalified.
• Ensure audit readiness and support internal/external inspections; manage CAPA for deviations, OOS, and audit findings.
• Oversee maintenance and operation of critical sterile manufacturing equipment: filling machines, lyophilizers, autoclaves, and washing / depyrogenation tunnels.
• Ensure thorough cleaning and sanitization of all clean rooms in compliance with SOPs.
• Maintain equipment and production areas in a validated state at all times.

Required Qualification, Experience and Skills:

• B. Pharma / M. Pharma / B. Sc / M. Sc with 12 to 15 years in sterile injectable manufacturing, with at least 4 years in a leadership role.
• Strong knowledge of aseptic manufacturing, sterile area operations, and regulatory compliance.
• Hands-on experience in vial/ ampoule/PFS/Lyo production lines.

Familiar with equipment qualification, cleanroom operations, and environmental monitoring.