Quality Assurance Manager for Qualification und Validation 60-100% (m/f/d)
For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated Quality Assurance Manager for Qualification & Validation for one year with option for extension.
- 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
- 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
- Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator
Are you interested? Do not hesitate and submit your complete application documents online today.
We value diversity and therefore welcome all applications – regardless of gender, social origin, religion/belief, age or identity.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
60 – 100%