Quality Assurance Manager for Qualification and Validation

Quality Assurance Manager for Qualification and Validation – quality/ISO13485/FDA/german/english

Project / Role:
For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Quality Assurance Manager for Qualification and Validation

Background:

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 (e.g. 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 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.: 920238SGR
Role: Quality Assurance Manager for Qualification and Validation
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 01.06.2021
Duration: 6++
Deadline: 24.05.2021

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.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

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.