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Senior CAPA Consultant
Eingestellt von Edelway
Gesuchte Skills: Consultant, Engineering
Projektbeschreibung
Senior CAPA Consultant
One of our best clients, a global multinational company based in the Bern 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 coordinate and approve CAPA processes at individual plants.
Working language: German and English.
Start date: Asap - within one month from offer
Duration: 6 months initially. Extensions for the right profile
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 industry
*Knowledge of regulation and standards like ISO 13485, 21 CFR 820
*Fluent German and English is a must
*Technical education (engineering degree) or extensive experience in the relevant field of expertise
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
One of our best clients, a global multinational company based in the Bern 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 coordinate and approve CAPA processes at individual plants.
Working language: German and English.
Start date: Asap - within one month from offer
Duration: 6 months initially. Extensions for the right profile
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 industry
*Knowledge of regulation and standards like ISO 13485, 21 CFR 820
*Fluent German and English is a must
*Technical education (engineering degree) or extensive experience in the relevant field of expertise
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management