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Manager Microbiological Quality Control, Lengnau

Location Lengnau, スイス Job Id R-01306161 Job Type フルタイム Category 品質・薬事 Remote すべてオンサイト
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JOB DESCRIPTION

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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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