Your tasks:
* Manage and support continuous improvement of the QM system related to GCP
* Represent QA in Team meetings
* Contribute to evaluate and manage protocol deviations and GCP violations
* Provide QA advice to internal staff and external vendors
* Plan, prepare, conduct and follow-up GCP audits (investigator sites, vendors,
* processes, systems, documents)
* Manage external GCP-QA related service providers and external auditors
* Lead internal inspection readiness activities with respect to GCP
* Prepare, conduct and follow-up internal GCP related inspections
* Prepare, host and manage GCP inspections by health authorities and audits by
* external partners
* Conduct QA review of clinical trial specific documents as requested
* Support the selection and qualification of GCP providers
* Conduct of internal trainings related to GCP
Your requirements:
* University degree in biology, biochemistry, chemistry, medicine or related
* discipline
* Ideally at least five years professional experience in the area of GCP - preferable
* some experience in QMS/QA
* Fluent in written and spoken English
* Expert knowledge in the area of GCP and in national and international
* regulations (mainly EU and US)
* Excellent Team Player and strong, hands-on personality
* German work permit is mandatory
Benefits:
* Flexible working time
* Mobile working (up to 3 days of home office)
* 30 days paid vacation
* Group accident insurance
* Continuing education offers
* Team spirit, great working atmosphere and much more
If interested please apply directly
