Validation Specialist - Senior

Vor Ort
11 Months
Real Staffing
flag_no Schweiz

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11 Months Project - Validation Specialist - Senior

-Provides expertise on Cleaning Validation, Hold Time Validation, Mixing Validation, Process Validation, Packaging Validation
- Assures compliance to regulations.
- Participates in setting directions for the Validation Department as well as priorities of activities.
- Responsibility to observe the necessary caution and carefulness in order to avoid dangers for the safety or health of themselves or others and for the environment, when carrying out activities
- Developing, maintaining and improving validation activities to meet with current/future industry and regulatory standards.
- Develop, maintain and improve the Validation Quality system for compliance, effectiveness and efficiency purposes.
- Provides expertise to the management and validation executing departments regarding validation issues.

- German (Swiss German prefered) and English fluent
- Bachelor degree or proven qualification in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology, engineering, supplemented with additional training during working-life.
- At least 3 years experience in a pharmaceutical or related industry, of which at least 2 years of validation experience.
- Experiance with the FDA Process validation Guideline is a must.
- Experiance as a Subject Matter Expert on Validation Quality System during Inspections.
- Experiance with dtV CTQ and CQA

For more information about this role or jobs within related specialist areas please send me your CV with your hourly rate expectation for immediate consideration.
You can reach me on

Due to the urgeny of this role my client is not able to provide candidates from outside the EU25/EFTA nations with work permits for Switzerland.

Keywords: Medical Device, Validation, FDA Process Validation Guideline, Quality System, dtV CTQ, CQA, German, English, Freelance, Switzerland

Campaign Ref: CH

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