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| Company: |
Kelly services (Suisse) SA |
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| Job Title: |
Quality IT Specialist |
| Job category: |
Information Technology |
| Job Location: |
Switzerland |
| Job Description: |
Leading the implementation of IT Quality Systems in compliance with applicable medical devices and pharmaceutical regulations, operational requirements and facility strategic objectives.
- In collaboration with concerned departments, establishes a project plan to implement IT quality systems
- Develops and provides training to users.
- Writes associated documentation
- In collaboration with Quality Engineering, leads the validation of new systems
Ensuring continuous support and administration of IT Quality Systems (deviation management, documentation system, training).
Provides support to ensure continuous compliance with applicable regulations
Provides support in monitoring of quality systems performance
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Skills Required:: |
University degree or equivalent through experience with preferably 1 year or more in a Quality environment in the healthcare industry.
Knowledge of EN13485, Medical Devices Directive (93/42-EEC - 2007/47/EEC) and Quality Systems and / or knowledge of FDA/QSR and European pharmaceutical cGMP
Rigorous and systematic in the application of Quality Management System requirements.
Good knowledge of, and proficiency in specific IT tools is a plus: deviation management (e.g. TrackWise), documentation management (e.g. Documentum), visual business process management (e.g. WinDesign), Learning Management systems.
Result-oriented.
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Language Requirements: |
English-Very GoodFrench-Very Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-10-09 |
| Level of Education: |
Bachelor |
| Years of Work Experience: |
1 to 2 Years |
| Company: |
Kelly services (Suisse) SA |
| Contact Name: |
Kelly Scientific Resources |
| Contact Phone: |
0041 22 737 12 01 |
| Contact Fax: |
0041 22 737 12 13 |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
French |
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