CAPA Senior Consultant - Process Expert in Pharmaceutical Industry

CAPA Senior Consultant required with knowledge of Pharmaceutical industry processes and excellent German language skills.

The main objective of this role is to coordinate and approve CAPA processes at individual plants.

The responsibilities of this position include:

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 and DCR/DCODevelop a risk assessment

Develop evaluation of errors and NCR at the factory, as well as improvements

What we require from the candidate:

- practice and full understanding of CAPA process in medical device or pharmaceutical industry
- knowledge of regulation and standards like ISO 13485, 21 CFR 820
- fluent German is a must
- fluent English
- technical education (engineering degree) or extensive experience in the relevant field of expertise