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Merck KGaA
Manager Qc Microbiology & Environment Monitoring (All Genders)
Posted on Dec. 4, 2024
- Aubonne, Switzerland
- No Salary information.
- Full Time
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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
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 a 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 of the integrity of the data created in conformity with the « Data Integrity rules ».
As a “go-to" Manager, you ensure the above is performed in accordance with the cGMPs, regulatory requirements and company standards. You also successfully present and/or defend all the above in Inspection or Audit.
You will report to the Head of Quality Control, you liaise with peer QA and QC and production managers and you allow the QC testing labs to run smoothly whilst managing experienced collaborators eager to develop (themselves, the team, the company) in a context of growth, simplification, and changes.
Who you are:
- 5+ years of experience in QC Microbiology activities in relation with Biotechnology/Aseptic processing in GMP environment
- Proven ability to learn & adapt quickly
- Proven experience as supervisor/manager with leadership skills
- Team player with advanced communication skills in French & English
- Awareness of pharmaceutical and regulatory requirements
- Previous successful experience in positions interacting with other departments/sites
- Advanced knowledge in part of the QC Microbiology activities and Aseptic processing scope depicted above and ability to bring a plus to the team and peers
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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