Senior CAPA Consultant

Bern  ‐ Vor Ort
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Beschreibung

Senior CAPA Consultant

One of our best clients, a global pharmaceutical company based in the Bern/Basel area, is currently looking for a Senior CAPA Consultant to join them on a long term basis. The main objective of this role is to provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with our client's standards and Regulations.

Start date: Asap - within one month from offer.

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

Start
keine Angabe
Von
Edelway
Eingestellt
05.07.2013
Projekt-ID:
562717
Vertragsart
Freiberuflich
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