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Quality Engineer
Eingestellt von Edelway
Gesuchte Skills: Engineer, Sap
Projektbeschreibung
Quality engineer- Materials Controls
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Quality engineer- Materials Controls to join them on a long term basis (contract or permanent).
Language: English & German, other languages are a plus
Start Date: ASAP
Rate: Excellent
THE ROLE:
*Provide consultancy and guidance related to Materials Control.
*Excellent knowledge of 21CFR 820 different subparts as well as ISO 13485.
*Conduct remediation activities related to existing processes about materials segregation and different logistical procedures within the manufacturing sites
*Audit sites' procedures to the standards and provide recommendations with regards to compliance.
*Perform CAPA verificiation of effectiveness as necessary.
*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards for the Medical
Device Industry (ISO, FDA, etc.).
YOUR PROFILE:
*Minimum of 4 years quality/compliance experience in the medical device or pharmaceutical industries.
*Perform, analyze and define Inspection Plan as necessary.
*Be willing and able to travel to other sites as required (primarily Switzerland, Germany, Austria).
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Generate DCRs/DCOs that these achieve the regulatory and the business requests.
*Compliance experience in the medical device.
*Prior experience in medical device/pharmaceutical remediation preferred.
*Documented training in FDA QSR, ISO 13485/9001 required.
*Proficient in Microsoft Office, MS Visio is a plus
*Knowledge in ERP systems (preferably Agile, JD Edwards, SAP)
*Excellent organizational skills and be able to manage effectively multiple priorities and tasks, readiness to take on responsibility, reliable, proactive and self-driven
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Quality engineer- Materials Controls to join them on a long term basis (contract or permanent).
Language: English & German, other languages are a plus
Start Date: ASAP
Rate: Excellent
THE ROLE:
*Provide consultancy and guidance related to Materials Control.
*Excellent knowledge of 21CFR 820 different subparts as well as ISO 13485.
*Conduct remediation activities related to existing processes about materials segregation and different logistical procedures within the manufacturing sites
*Audit sites' procedures to the standards and provide recommendations with regards to compliance.
*Perform CAPA verificiation of effectiveness as necessary.
*With oversight from the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards for the Medical
Device Industry (ISO, FDA, etc.).
YOUR PROFILE:
*Minimum of 4 years quality/compliance experience in the medical device or pharmaceutical industries.
*Perform, analyze and define Inspection Plan as necessary.
*Be willing and able to travel to other sites as required (primarily Switzerland, Germany, Austria).
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Generate DCRs/DCOs that these achieve the regulatory and the business requests.
*Compliance experience in the medical device.
*Prior experience in medical device/pharmaceutical remediation preferred.
*Documented training in FDA QSR, ISO 13485/9001 required.
*Proficient in Microsoft Office, MS Visio is a plus
*Knowledge in ERP systems (preferably Agile, JD Edwards, SAP)
*Excellent organizational skills and be able to manage effectively multiple priorities and tasks, readiness to take on responsibility, reliable, proactive and self-driven
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik