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Medical Device Compliance & Quality System Documentation Specialist
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Support, Design
Projektbeschreibung
Randstad Professionals is actively looking for a motivated and open-minded Medical Device Compliance & Quality System Documentation Specialist to join our client in Basel, Switzerland.
The Document Specialist within Device Developments Documentation and Compliance Group will support the Documentation and Compliance Group with regard to Quality Systems Regulations, Medical Device Directives, Genentech standards and Training activities.
Additionally, he/she will deal with the Corporate Records Management (Coremap) requirements ensuring compliance for the department and support the Development of appropriate infrastructure aspects to support operational activities.
Main responsibilities:
Dealing with COREMAP Requirements in Device Development for documents, adopt documents to archival requirements and cleanup activities.
Support the Documentation and Compliance Group in preparing
Documents for Quality System Documentation, establish and maintain Technical Documentation according requirements outlined in the Medical Device Directive and 21 CFR820 for Medical Devices and Design History Files
Training administration
Actively contribute to improvement of documentation management systems, business processes and procedures, ensure Good Documentation Practices
Perform any other tasks as requested by Management to support Documentation and Compliance activities
Qualifications:
Experience in working in pharmaceutical, biotech, diagnostics, medical device or healthcare industry under cGxP, QSR or similar working practices
Excellent knowledge of cGMP`s and relevant international regulatory requirements, quality system experience,
Excellent documentation management and documentation skills
Sound knowledge of Quality Systems Regulations including device design controls, and Medical Device Directives (eg ISO 13485 and FDA CFR 21 Part 11, Part 820)
Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.
Excellent IT knowledge
If you are ready for a new opportunity, please don't hesitate to contact us!
Good to know you
The Document Specialist within Device Developments Documentation and Compliance Group will support the Documentation and Compliance Group with regard to Quality Systems Regulations, Medical Device Directives, Genentech standards and Training activities.
Additionally, he/she will deal with the Corporate Records Management (Coremap) requirements ensuring compliance for the department and support the Development of appropriate infrastructure aspects to support operational activities.
Main responsibilities:
Dealing with COREMAP Requirements in Device Development for documents, adopt documents to archival requirements and cleanup activities.
Support the Documentation and Compliance Group in preparing
Documents for Quality System Documentation, establish and maintain Technical Documentation according requirements outlined in the Medical Device Directive and 21 CFR820 for Medical Devices and Design History Files
Training administration
Actively contribute to improvement of documentation management systems, business processes and procedures, ensure Good Documentation Practices
Perform any other tasks as requested by Management to support Documentation and Compliance activities
Qualifications:
Experience in working in pharmaceutical, biotech, diagnostics, medical device or healthcare industry under cGxP, QSR or similar working practices
Excellent knowledge of cGMP`s and relevant international regulatory requirements, quality system experience,
Excellent documentation management and documentation skills
Sound knowledge of Quality Systems Regulations including device design controls, and Medical Device Directives (eg ISO 13485 and FDA CFR 21 Part 11, Part 820)
Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.
Excellent IT knowledge
If you are ready for a new opportunity, please don't hesitate to contact us!
Good to know you
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges