company (CDMO) for bio-pharmaceutical. The company makes a decisive contribution to the
worldwide availability of essential therapies and are expanding their team. Become part of
this unique team and shape the future of the bio-pharmaceutical industry.
As of a result of growth, the company is looking to expand their Quality Department and are
looking for a QA Manager Audit and Inspections.
Responsibilities:
* Organisation and management of customer audits and official inspections on site and
remotely
* Carrying out self-inspections in the GMP areas of the company
* Direct contact for authorities and customers with regard to all questions regarding
inspections and audits
* Processing of inquiries from authorities with regard to GMP issues
* Direct contact to local authorities regarding manufacturing authorisation and GMP
certificates
* Interface to SMEs from the individual departments as part of audits/inspection
management
* Tracking of the processing of audit observations and creation of key figures
* training of employees
* Continuous optimisation of the preparation, implementation and follow-up of
inspections and audits, also in cooperation with other sites
Technical Competencies and Experience
* Scientific education preferably in biotechnology or pharmaceutical technology or
comparable qualification
* Several years of experience in organising and conducting audits/inspections desirable
* Comfortable with engaging with external partners
* Independent work and a high degree of responsibility
Preferred
* Experience with management of virtual audits/inspections
