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Quality Assurance Manager for Qualification and Validation

ITech Consult

Posted on Jun 8, 2021 by ITech Consult

Zug, Switzerland
1 Jul 2021
Annual Salary

Quality Assurance Manager for Qualification and Validation - quality/ISO13485/FDA/German/English

For our customer 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.

Main Tasks

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

Must Have:
* 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 and plant qualification)
. Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.

Reference No.:
Role: Quality Assurance Manager for Qualification and Validation
Industry: Pharma
Workload: 80-100%
Deadline: 10.06.2021

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.

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.

Reference: 1221274973

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