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Senior Quality Manager
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Support, Client
Projektbeschreibung
On behalf of our client in the Life Science industry, Harvey Nash is looking for a Senior Quality Manager for a 2 year project in Switzerland.
The role is about managing projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is maintained in TRD.
You are responsible for
- Approval of GMP relevant documents and decision making according to current SOP ("Global TRD QA and TRD Approval and Release Authorities") for the authority of QA Associate and special authority for DSM, and finally with authorities delegated to QA Team Leader of QA DSM
- Releasing authorities for clinical materials according to current SOP ("Global TRD QA and TRD Approval and Release Authorities"), with the authority of QA Associate and special authority for DSM and finally with authorities delegated to QA Team Leader of QA DSM
- Managing Deviations, Investigations, CAPAs and contributes to or writes trending reports for level 2 Deviations/FIRs/Technical Complaints/Change requests for products and processes of TRD GMP line units and recommends necessary actions to supervisor (Quality Matrix)
- Contributing to or writing First Time Right performance reports for release of IMPs
- Quality system: write/review SOPs, contribute to the review of new Quality Modules/Quality Directives, performs gap assessments for the implementation of new Quality Modules/Quality Directives
- Supporting DSM in process improvements and in Qualityfluent in German desirable
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
The role is about managing projects and/or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is maintained in TRD.
You are responsible for
- Approval of GMP relevant documents and decision making according to current SOP ("Global TRD QA and TRD Approval and Release Authorities") for the authority of QA Associate and special authority for DSM, and finally with authorities delegated to QA Team Leader of QA DSM
- Releasing authorities for clinical materials according to current SOP ("Global TRD QA and TRD Approval and Release Authorities"), with the authority of QA Associate and special authority for DSM and finally with authorities delegated to QA Team Leader of QA DSM
- Managing Deviations, Investigations, CAPAs and contributes to or writes trending reports for level 2 Deviations/FIRs/Technical Complaints/Change requests for products and processes of TRD GMP line units and recommends necessary actions to supervisor (Quality Matrix)
- Contributing to or writing First Time Right performance reports for release of IMPs
- Quality system: write/review SOPs, contribute to the review of new Quality Modules/Quality Directives, performs gap assessments for the implementation of new Quality Modules/Quality Directives
- Supporting DSM in process improvements and in Qualityfluent in German desirable
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges