Requirements: English
Company: Thermo Fisher Scientific Inc.
Region: Lengnau , Argovia
Work Schedule
Other
Environmental Conditions
Office
Job Description
Crafted advanced manufacturing facility for large-scale biologics production with high expansion potential.
Lead the Microbiology Unit (MBQC) at Thermo Fisher''s Lengnau site as part of the Quality Control management team.
Your responsibilities:
- Ensure the continued update of the operational procedures related to the QC area to align with the latest quality requirements
- Lead, develop and maintain GMP innovative laboratories for Microbiological analytics and ensure procedural documents are in place to accurately lead Microbiological related processes and testing
- Responsible for the sampling team that comprises clean utilities, environmental monitoring, and raw material samples
- Ensure MBQC labs are always ready for Health Authorities inspection (audit readiness) and Customer visits
- Coordinate the timely evaluation, development, validation, and re-validation of Microbiological QC test procedures as well as coordinate the evaluation, procurement, qualification, re-qualification, maintenance (service/cleaning), calibration, and monitoring of equipment
- Collect QC analytical samples and required materials promptly, ensuring availability of all necessary "reference and control" materials.
- Timely execution and evaluation of analytical testing (either internally or externally tested) to ensure business expectations are met
- Ensure testing results are detailed according to GDP and in a way to preserve data integrity
- Consistent and timely investigation of OOE/OOS-results and laboratories deviations
- On demand, support and lead internal QC/QM/LGN projects
Your qualifications:
- University Degree (Master or higher) in Microbiology, Biology, or Life Science
- Many years of experience in a highly regulated industry (GxP, Food, Medical Device)
- Proven experience as a people manager in quality control
- Confirmed experience and knowledge in Microbiological QC methods, method validation, and analytical issue management
- Knowledge in sampling of utilities, environmental monitoring samples, and raw materials
- Able to lead by example, providing technical and personal support
- Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks at the same time
- Working proficiency in English and the ability to communicate in German is required
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