Description
Jobs | ITechMedical Quality Assurance Manager CSV
About us: ITech Consult AG is a certified ISO Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Reference No.: 916466KS
Role: Medical Quality Assurance Manager CSV
Industry: Medical
Location: Luzern und Region; Switzerland
Workload: 100%
Start Date: ASAP
Duration: 31.12.2017 (+)
Job Description:
- Assure that CSV activities as well as qualification, validation, equipment management activities within the area of responsibility of the department are completed in time and documented in a traceable manner.
- Assure that corrective and preventive action as well as effectiveness checks within the area of responsibility (e.g. CAPA cases) of the department are completed in time and documented in a traceable manner.
- Support and consult the business partners of the department in the area of CSV activities or qualification, validation, equipment management as assigned.
- Assurance and continuous monitoring of cGMP compliance (e.g. FDA, IVDD, ISO) at RDI within the area of responsibility of the department.
- Support and/ or performance of assigned, general and specific tasks within the area of responsibility of the department.
- Performance of trainings within the area of responsibility of the department.
Job Responsibilities:
- Handling and/ or review of Periodic Reviews for CSV according to daily business - Performance of SOP trainings, support meetings and workshops - Acting as Process Advisor regarding IT procedures - Acting as Process Advisor regarding CSV - Updating the local computer system inventory - Validation support for SAP review and system risk assessment
Skills required:
- At least 5 years of experience in area of medical devices and especially CSV
- Qualification for CSV topics or similar - Qualification for Qualification & Validation or similar
-SAP user ID - Sharepoint - MS Office
Languages:
- German - Proficient - English - Good