Directs batching and pre-weigh activities daily. Responsible for maintaining schedule and attendance and organizing overtime when needed. Manages breaks and lunch adherence.
Implement effective communication across all shifts utilizing a handover process or communication board.
Supports scheduled production by meeting shift goals and expectations and implementing additional training or discipline if needed when goals are not met.
Ensure all staff meet required standards for all cGMP standards including cleaning and sanitization by auditing and training employees.
Implement best practices to maximize efficiency across batch time by analyzing current practices and implementing improvements or implementing engineering modifications to decrease batch time and meet target business needs.
Implement effective FIFO practices and raw material warehouse utilization so that proper materials are used in order and maximize efficiencies in warehouse storage and movements.
Implement and manage pre-weigh processes that result in accurate raw material inventory.
Ensure raw material locations are updated and correct in ERP system.
Assures equipment usage logs, cleaning logs, Chemical usage and calibration verification logs are completed in a timely fashion and are inclusive of all requirements.
Mitigates and reduces the need for Planned Deviations.
Drive efficiency through batching to optimize capacity.
Coordinate the preventative maintenance requirements with maintenance to ensure compliance to PM schedule.
Assure that all equipment ins in a proper state of repair and in a compliant cGMP condition as required. Adheres to the Maintenance Work order system to communicate repairs and replacements to maintenance, preventing downtime in compounding.
Manages the Equipment Washing Room and the coordination of the ancillary equipment cleaning and storage.
Skills and Requirements
Bachelors Degree in Engineering or other associated discipline or relevant experience
5-10 years experience in batching in a FDA production environment
Good Verbal and written skills (English)
Excellent knowledge of chemical and batch processing
ERP experience preferred