Beschreibung
THE ROLE
* Ensuring the availability of an overview of all CAPAs (corrective and preventive actions) and supporting users & stakeholders in the factory.
* Consultancy and guidance of all employees regarding CAPA requirements (external and internal)
* Training and motivating the involved employees in the CAPA process-Monitoring of work
* Reporting to the QPM Manager regarding all progress and obstacles
* Bringing in of improvement proposals, which increase the productivity and efficiency of the CAPA-process and provide active support to reach the settled goals
* Know and follow the guidelines with regard to codes of conduct, ethics and compliance programs, as well as other relevant Regulations especially ISO 13485, 21 CFR 820
* Make sure that CAPAs in accordance with regulatory requirements (ISO 13485, 21 CFR 820) and internal requirements to be implemented
* Assists in NCR (Nomenclature Change Request) and DCR/DCO (Document change request/order)
* Develop a risk assessment
* Develop evaluation of errors and NCR at the factory, as well as improvements
YOU NEED
* Practice and full understanding of CAPA process in pharmaceutical or medical devices industry
* Knowledge of regulation and standards like ISO 13485, 21 CFR 820
* Demonstrated leadership ability
* Fluent English. German is a plus.
* Technical education (engineering degree) or extensive experience in the relevant field of expertise