Quality Assurance Manager for Qualification and Validation
Posted on May 24, 2021 by ITech Consult
Quality Assurance Manager for Qualification and Validation - quality/ISO13485/FDA/German/English
For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Quality Assurance Manager for Qualification and Validation
The RDI Quality function consists of three departments: QM Systems, Design Quality Assurance and Operations Quality Assurance. The Candidate will be a team member of the Qualification & Validation Quality Team within Operations Quality Assurance.
. Provide independently Quality process support for computerized system validation (CSV) helping business partners from Development and Operations to develop a compliant validation strategy based on system and functional risk assessment including security and data privacy requirements.
. Provide independently Quality process support in the area of qualification & validation (equipment, process, analytical methods) 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)
. 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, all related documents to process/method/computerized system validation)
. Identify opportunities for optimization of operational procedures in order to improve quality and efficiency within area of responsibility
. Conduct training for Qualification & Validation processes and continuously monitor key performance indicators
* Technical or scientific degree or completed education in a technical profession.
. At least 3 years of professional experience with quality management preferably in relation to ISO 13485, FDA and Quality Systems Regulations.
. At least 3 years of professional experience in governance of qualification and validation processes in the area of medical devices or in vitro Diagnostics
. Very good German language skills (B2 or higher) and good English verbal and written language skills
. For supporting the business partners in the different areas experiences in production areas is a plus.
. Good judgment & negotiation skills
. strong experience in qualification. (Equipment qualification)
. Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.
-Willing to work on site!
Reference No.: 920238SGRRole: Quality Assurance Manager for Qualification and Validation
Industry: Pharma Location: Rotkreuz Workload: 100% Start: 01.06.2021 Duration: 6++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
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.