Posted:1 day ago|
Platform:
On-site
Full Time
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.
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