Quality Control Manager - Microbiology Belgium Company information
As the world leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial, and applied markets, generating $30 billion in annual revenue. No other company can match our range of customer touchpointstechnologically, geographically or commercially. We help customers in finding cures for cancer, protecting the environment, making sure our food is safe, and moving forward with thousands of important projects that improve millions of lives. At Thermo Fisher, we give our 70,000 extraordinary minds the resources and opportunities to make significant contributions to the world.
How will you make an impact?
Responsible for overseeing all microbiology testing and environmental monitoring within the QC Microbiology department for a cGMP biopharmaceutical manufacturing facility. The Manager will be a key member of the management team and will be responsible for the design, implementation, and continuous improvement of all... processes/systems in support of the Gosselies Manufacturing plant and utilities.
What will you do?
· Oversee the Quality Control Microbiology laboratory strategy and operation with a focus on facility utilities, environmental classification and control design, microbiology equipment, and facility qualification/control.
· Oversee the Aseptic Gowning and Training program.
· Support QC and manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC-related topics.
· Maintain a robust environmental monitoring program that meets applicable regulatory requirements.
· Organize and direct cross-functional relationships with Manufacturing, Engineering, Facilities, MST, and Quality Assurance.
· Manage laboratory staff, set goals and expectations and maintain efficient utilization of resources.
· Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
· Ensure continued professional development of staff through training and functional interactions with various operating groups.
· Participate in inspections for regulatory/internal/customer
· Reviews laboratory investigations in response to invalid assays, Deviations, OOS/OOT.
· Ensures that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures
· Assist with developing solutions to a variety of problems of moderate scope & complexity. Refers to policies & practices for guidance.
· Presents analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
· Manage team of analysts and associated supervisors.
· Requires BS in Microbiology or related life sciences discipline.
· At least 7+ years of relevant experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or project management experience.
· Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.
· In-depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.
Knowledge, Skills, Abilities
· Has good technical understanding and application of principles, concepts, practices in the area of microbiology.
· Ability to communicate at all levels and across various functions
· Handle issues appropriately and with a sense of urgency
· Ability to problem solve and identify the root cause
· Flexible to meet changing demands to support manufacturing activities.
· Completes tasks where judgment is required in resolving problems and recommendations.
· Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
· Frequent use & general knowledge of industry practices, techniques, and standards.
· Strong interpersonal and communications skills; written and oral.
· Understanding of applicable regulatory requirements Belgium undefined undefined
Quality Control Manager - Microbiology Belgium Thermo Fisher Belgium