Control Room Specialist
2 maanden geleden
The opportunity
Take charge of coordinating, managing, and monitoring all process-related activities from our centrally located Control Room at our aseptic manufacturing site. As a Control Room Specialist, you will lead and guide a team of operators, specialists, and technicians. Your role is pivotal in ensuring strict adherence to quality standards, including GMP guidelines, safety regulations, and SOPs, to drive optimal production processes.
You will work in 24/7 shifts.
How you’ll spend your day
Coordinate and oversee personnel and production planning in collaboration with the Shift Managers. Monitor and adjust automated processes, workflows, and production activities. Authorize production activities based on measurement and analysis results (PMS system, free weigh results). Operate freeze dryers from the Control Room. Identify and promptly report deviations and malfunctions, halting operations if guidelines and procedures are compromised. Explain, monitor, and enforce quality and safety regulations among personnel. Coordinate and resolve equipment and process issues with support departments (E&M, QA, QC). Provide functional leadership to operators, specialists, industrial cleaners, and technicians. Schedule tasks and optimize workforce and production resources. Monitor and evaluate data and documentation in the Control Room. Generate, collect, and review batch documentation and process reports. Coordinate, register, and report Maintenance and Utilities activities. Log deviations, malfunctions, and incidents in Trackwize. Handle MCPS alarms and create and evaluate PMS reports. Propose improvements and provide input from the shop floor. Collaborate with other departments, sharing knowledge, experiences, and insights.Your experience and qualifications
HBO level or equivalent education, preferably in Pharmacy, Chemical Technology, or a related field Knowledge of pharmaceutical processes (septic and aseptic) Familiarity with production control systems and planning techniques Understanding of quality assurance systems Knowledge of Lean Six Sigma and Operational Excellence Experience in a coordinating role within a production organization Strong communication skills and leadership abilities Proficiency in English and Dutch (spoken and written) Planning, organizational, reporting, and documentation skills Ability to perform under pressure and strong analytical skills Training and knowledge transfer abilities Results-oriented with an understanding of cause and effect Teamwork and collaboration, team leadership, and people management-
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