30 Jul
|
Care Group
|
India
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 settings.
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.
Experience: 12 years in parenteral (injectables) manufacturing OR Fresher
Knowledge: Solid understanding of GMP regulations, sterile area behaviors, and aseptic techniques.
Skills: Technical proficiency in parenteral manufacturing machinery, troubleshooting, documentation, and leadership.
📌 Production Executive Padra (India)
🏢 Care Group
📍 India