Production Executive/Supervisor

To execute and monitor sterile manufacturing operations in compliance with current Good Manufacturing Practices (cGMP) and company SOPs. The Production Executive is responsible for ensuring safe, efficient, and compliant manufacturing of sterile buffer products while maintaining product quality and productivity.

Key Responsibilities

• Execute daily production activities as per approved Batch Manufacturing Records (BMR).
• Operation of Mixing vessel, Autoclave and other production equipment.
• Perform area cleaning and preparation of disinfectant solution.
• Perform dispensing, mixing, filtration, filling, visual inspection, and packing activities.
• Monitor manufacturing parameters throughout production.
• Ensure proper line clearance before commencement of every batch.
• Ensure aseptic operations in Grade A/B cleanrooms.
• Ensure proper aseptic techniques are followed by all operators.
• Coordinate with Microbiology for environmental monitoring activities.

Required Skills

• Strong knowledge of sterile buffer manufacturing processes.
• Thorough understanding of aseptic processing and contamination control.
• Familiarity with cleanroom classifications (Grade A, B, C & D).
• Knowledge of sterile filtration, autoclaves and depyrogenation.
• Strong documentation skills with Good Documentation Practices (GDP).
• Working knowledge of ALCOA+ Data Integrity principles.
• Proficiency in Microsoft Office and ERP/QMS systems.
• Good communication and team coordination skills.