A leading partner to the Pharma/Biotech industries is expanding their operations on their site in Planegg, near Munich, Germany. This company is involved across various product and therapeutic areas, so there is the opportunity to get hands on a variety of products.
YOUR TASKS
As a team leader in the growing Quality department, you are responsible for the ongoing development of team.
- You lead internal and external audits as the first point of contact for authorities and the notified body, and assume responsibility for the preparatory and follow-up measures.
- You are responsible for the qualification of external partners (e.g. suppliers, contract manufacturers) and you and your team are responsible for CAPA management.
- You monitor the maintenance and updating of the QM system (manual, site master files, SOPs, etc.)
- You act as an interface in the area of โโregulatory affairs, accompany approval procedures and develop quality advance planning in relation to the development and introduction of (new) products.
- Your work will be rounded off with the supervision of the training system, the control of manufacturing documentation and the participation in product development projects.
YOUR PROFILE / YOUR PROFILE
- You have successfully completed a degree in pharmacy, natural sciences or a similar qualification.
- You have at least five years of relevant professional experience in a pharmaceutical company or a regulated work environment and have in-depth management experience.
- An analytical, precise and forward-looking working style, paired with a creative approach, is a matter of course for you.
- In addition to good communication and organizational skills, you also have very good written and spoken German and English.
