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CAPA Specialist
Eingestellt von Edelway
Gesuchte Skills: Design, Engineer
Projektbeschreibung
CAPA Specialist
Edelway is a Swiss IT services company currently searching for one of our globally acting clients in the medical industry a Packaging Engineer. This is a temporary role based close to Zurich.
THE ROLE AND RESPONSIBILITIES
*Project leader with responsibility for handling, processing and documentation of packaging related CAPAs
*Performing and review of risk assessments (p-FMEAs and d-FMEAs) especially considering potential damage to the sterile barrier
*Checking for compliance with 21 CFR 820 and ISO 13485 (Design Control, Protocols, Hazard Identification, reports etc.)
*Causal analysis for packaging related CAPA taking into account the checking of identification, traceability, manufacturing orders, supply chain, complaint screening
*Verifying of packaging design compliance and packaging process validity according to ISO 11607
*Implementation of remediation actions to ensure compliance
*Partial preparation of Health Hazard Evaluation (HHE)
*English and German essential
If you are interested in this excellent opportunity, send us your CV in English as a word document and we will call you to discuss it. Or feel free to call Nena.
Keywords:
Packaging, CAPA, ISO, HHE, Hazard Identification, Quality Assurance
Edelway is a Swiss IT services company currently searching for one of our globally acting clients in the medical industry a Packaging Engineer. This is a temporary role based close to Zurich.
THE ROLE AND RESPONSIBILITIES
*Project leader with responsibility for handling, processing and documentation of packaging related CAPAs
*Performing and review of risk assessments (p-FMEAs and d-FMEAs) especially considering potential damage to the sterile barrier
*Checking for compliance with 21 CFR 820 and ISO 13485 (Design Control, Protocols, Hazard Identification, reports etc.)
*Causal analysis for packaging related CAPA taking into account the checking of identification, traceability, manufacturing orders, supply chain, complaint screening
*Verifying of packaging design compliance and packaging process validity according to ISO 11607
*Implementation of remediation actions to ensure compliance
*Partial preparation of Health Hazard Evaluation (HHE)
*English and German essential
If you are interested in this excellent opportunity, send us your CV in English as a word document and we will call you to discuss it. Or feel free to call Nena.
Keywords:
Packaging, CAPA, ISO, HHE, Hazard Identification, Quality Assurance
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik