Production Executive

Care Group; Padra; On-site; INR 600,000 - 800,000; Full time

Job summary

Care Group is seeking a Production Executive for the Parenteral Section in Gujarat, India. The role involves managing sterile manufacturing operations for prefilled syringes and vials, ensuring compliance with FDA regulations. Responsibilities include overseeing production processes, maintaining documentation, managing sterile environments, and leading teams. Candidates should have a B.Pharm or M.Pharm, with 12 years of experience in injectables manufacturing or be a fresher with a strong understanding of GMP standards.

Qualifications

• Minimum 12 years of experience in parenteral (injectables) manufacturing or fresher.
• Strong understanding of GMP regulations, sterile area behaviors, and aseptic techniques.

Responsibilities

• Oversee daily sterile production including formulation and filling.
• Ensure compliance with GMP documentation.
• Monitor clean room conditions and particle counts.
• Operate and supervise the maintenance of filling machines.
• Ensure product quality and adherence to safety protocols.
• Allocate manpower and provide training to team members.
• Participate in equipment qualification and process validation.

Skills

Technical proficiency in parenteral manufacturing machinery

Troubleshooting

Documentation

Leadership

Education

B.Pharm or M.Pharm

Job description

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.
• Experience: 12 years in parenteral (injectables) manufacturing OR Fresher
• Knowledge: Strong understanding of GMP regulations, sterile area behaviors, and aseptic techniques.
• Skills: Technical proficiency in parenteral manufacturing machinery, troubleshooting, documentation, and leadership.