At Roche Diagnostics, the business problem is to prevent, stop and cure diseases, and ensure everyone has access to healthcare today and for generations to come, specifically in the development of blood glucose monitoring and insulin delivery systems.
Requirements
- Project management and agile techniques
- Risk management.
- ISO-13485, 21 CFR Part 11 and GAMP 5.
- Working with Electronic Documentation Management Systems
- Good MS Office skills
Responsibilities
- You are responsible for validation planning of equipment and computer-based systems across various areas such as Operations, R&D, and Quality.
- You define the validation relevance and strategy, develop test specifications and traceability matrices as needed, ensure that all required prerequisites for starting validation are met, and coordinate the necessary validation phases and test contents with representatives from relevant interfaces.
- You review requirements, functional specifications, development tests, and software deployment. This includes performing content reviews and representing compliance aspects.
- You handle assigned tasks as part of changes and CAPAs
- You participate in internal and external audits.
- Maintaining the inventory database and contributing to the optimization of the validation process complete your range of responsibilities.
Other
- Bachelor’s degree in engineering or closely related scientific/technical discipline or equivalent work experience
- Relocation benefits are not available for this posting
- A discretionary annual bonus may be available based on individual and Company performance.
- This position also qualifies for the benefits detailed at the link provided below.
