Description
My Client is one of the largest Pharmaceutical Manufacturers worldwide. With around 20´000 employees he is expanding and currently seeking a CSV - Computer System Validation Specialist on a fixed contract basis (freelancer) in the area Medical DevicesRequirements:
- Creation of the validation documentation for the GxP relevant system elements
- Responsible for supporting Computer Systems Compliance activities applicable to country specific regulations (e.g. FDA), international standards (e.g. ISO) and as appropriate best business practices (e.g. GAMP 5). This includes the creation, execution and coordination of GxP computer system validation activities
- You have to be experienced in national and international regulations and standards FDA QSR, 21 CFR Part 820, Part 11, GAMP5, ISO 13485, ISO 62304
Profile:
- Fluent in English and German (Spoken and Written)
- Medical device and/or pharmaceutical experience are preferred
- A minimum of 3 years Computer System Validation
- For this role you bring preferred an IT background and higher education
- Preferred experience in audits
- Self-motivated and can adapt quickly in a new project and team
Duration: ASAP - 8 Months
Location: Canton Solothurn, CH
You feel that this project is something for you, then you can expect a challenging and varied job in a multicultural environment. Please send me your CV to , you can also call me on . I am looking forward to hearing about your current status, and to discuss any other vacancy.
Best Regards from Zurich
Magda Arnold
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