Job Title: Microbiological Quality Control Lead
About the Role:
We are seeking a highly skilled and experienced Microbiological Quality Control Lead to join our team. As a key member of our quality control management team, you will be responsible for leading the Microbiology Unit (MBQC) at our site.
Your Key Responsibilities:
* Ensure the continued update of 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 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, 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.