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Quality Assurance Manager for Qualifications and Validations - ITech Consult - HELP

Quality Assurance Manager for Qualifications and Validations - validation/English/FDA/ISO13485/German

For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Quality Assurance Manager for Qualifications and Validations

The RDI Quality function consists of three departments: QM Systems, Design Quality Assurance and Operations Quality Assurance. You will be a team member of the Qualification & Validation Team within Operations Quality Assurance

Main Tasks:
In this position you are responsible for the following tasks:
-Provide independently Quality process support in the area of qualification & validation, and equipment management for your assigned business partner
-Ensure sustainable compliance on site Rotkreuz Diagnostics International within area of responsibility (ISO 13485, FDA and Quality Systems Regulations)
-Conduct training for Equipment Management processes and continuously monitor key performance indicators
-Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility
-Enable your business partner to conduct qualification and validation activities and to create the required documentation efficiently
-Perform independent review and approval of process documents within area of responsibility (eg qualification plans & reports, equipment changes, process validation plans & reports, non conformances)

* Experience with quality management (ISO 13485) and the governance of qualification and validation processes
* Good communication & negotiation skills

Nice to Haves:
* Preferably expertise in quality management, in relation to ISO 13485 or FDA and Quality Systems Regulations
* Flexible and team player personality with the ability to assert yourself. You are used to work independently
* Roche or Pharma Experience
* GxP Experience

We are not searching for a CSV (Computerized System Validation).

Technical or scientific bachelor degree with minimum 5 years quality experience or a completed education in a technical profession with minimum 10 years quality experience environment

German and English fluent in written and spoken

Reference No.: 918898SST
Role: Quality Assurance Manager for Qualifications and Validations
Start: 17.02.2020

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT 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.