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QC Manager
Your role:
An exciting opportunity has arisen to join the Quality Control of Aubonne Bio-manufacturing Plant.
Enter a new era while entering new QC facilities, join the QC team as Quality Control Microbiology and Environmental monitoring Manager and contribute to deliver a consistent supply of quality medicines to patients.
As QC Microbiology & Environmental monitoring Manager, you lead 30+ collaborators dedicated to the testing and evaluation of raw materials, utilities, environmental monitoring samples, Drug Substance (DS), Biotechnology In Process Control and Drug Product (DP).
Purpose of the role:
* To manage the QC Microbiology & Env. Monitoring Laboratory and ensure that all related activities are performed in accordance with the cGMPs and regulatory requirements.
* To ensure a consistent customer focused analytical service.
* To guarantee the supply of quality products according to the established plan, good manufacturing practices, product registration, site quality standards, and manage within agreed financial limits.
* To ensure the use of validated/qualified analytical methods and equipment.
* To ensure the availability of reliable and accurate documentation in the laboratory.
* To support the transfer or implementation of new analytical test methods.
* To support the transfer of production processes including trials and validation batches according to company needs.
* To drive or participate in the continuous improvement programs in the laboratory, department and site.
* To generate the analytical part of the registered files in collaboration with the regulatory functions.
* To foster multiskilling in the laboratory.
* To ensure the integrity of the data created in conformity with the «Data Integrity rules».
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