Production Executive

Role Overview:

A Production Executive in the Parenteral Section manages sterile manufacturing operations (Prefilled Syringes & Vials) while ensuring compliance with FDA standards.

Key Responsibilities:

• Production Operations: Oversee daily sterile production, including formulation, filtration, filling, sealing, and sterilization (autoclave/tunnel) of parenterals.

• Documentation & Compliance: Ensure real-time maintenance of Batch Manufacturing Records (BMR), Batch Production Records (BPR), and equipment logs in compliance with GMP.

• Sterile Area Management: Monitor clean room conditions, particle counts (online/offline), and hygiene practices for sterile manufacturing environments.

• Equipment Handling: Operate and supervise the maintenance of equipment such as vial filling machines, PFS filling and sealing machines, vial washing systems, and autoclaves.

• Quality & Safety: Adhere to safety protocols and ensure product quality by preventing contamination during processing.

• Team Leadership: Allocate manpower per shift, ensure compliance with SOPs, and provide training to technicians and operators.

• Validation Support: Participate in equipment qualification (IQ/OQ/PQ) and process validation activities.

Required Qualifications & Skills:

• Education: B.Pharm or M.Pharm.

• Knowledge: Strong understanding of GMP regulations, sterile area behaviors, and aseptic techniques.

• Skills: Technical proficiency in parenteral manufacturing machinery, troubleshooting, documentation, and leadership.