Senior Associate

Job Description Summary

Senior Associate for the PFS filling line with Isolator System

Job Description

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.