Job Description

Summary
Senior Associate for the PFS filling line with Isolator System

Operational Oversight:Manage and monitor the filling and inspection processes for pre-filled syringes (PFS) within an isolator environment. Ensure smooth production operations across all assigned shifts. Person should be having the knowledge and skill about Sterile Injection facility.

Compliance and Documentation:Maintain adherence to cGMP guidelines, regulatory standards, and SOPs. Prepare and review batch manufacturing records, deviations, and CAPA documentation.

Equipment Management:Oversee the operation, cleaning, and maintenance of isolator systems, filling machines, and related equipment. Coordinate with maintenance teams for timely resolution of technical issues.

Team Supervision and Training:Lead and train the team to ensure productivity and compliance with safety protocols.


A person should have fundamental knowledge of quality management systems and be proficient in documentation activities, including the preparation of protocols, reports, and batch manufacturing records.