
Production Operations Coordinator
1 day ago
Key Responsibilities:
- Develop and implement standard operating procedures, batch manufacturing records, protocols, cleaning procedures, and log sheets.
- Ensure all documentation is in compliance with cGMP and regulatory requirements.
- Review and revise SOPs related to FP departments in a timely manner.
Quality Assurance Activities:
- Manage QMS activities including change controls, deviations, incidents, and risk assessments.
- Perform DQ, IQ, OQ, and PQ qualifications for equipment.
- Prepare the team for audits and ensure all documentation is ready.
Training and Team Coordination:
- Train departmental employees according to the TRIMS training schedule.
- Attend and participate in all relevant training programs, including cGMP and equipment-specific SOPs.
Production Execution:
- Execute formulation and aseptic filling activities as per the production plan.
- Lead simulation trials like media fills and ensure compliance in aseptic processing areas.
- Meet planned FP targets while adhering to cGMP guidelines.
Equipment Maintenance and Support:
- Coordinate with Engineering and QA for preventive maintenance plans execution.
- Monitor equipment performance and take necessary actions for uninterrupted operations.
Reporting and Communication:
- Perform daily operations as per schedule and report all activities, deviations, and issues to the reporting officer promptly.
- Update logbooks and ensure batch documentation is updated in real-time.
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