EINFÜHRUNG :
As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for a motivated
QA Manager Combination Product and Device (m / f / d)
This is a full / part-time position (80-100%) with an unlimited duration. The ideal start date is asap or 01.02.2025. Remote / Home Office : max. 2 days per week.
AUFGABENBESCHREIBUNG :
- Serve as the Quality SPOC (single point of contact) for allocated Device Development project and ensure all projects follow the applicable design control and risk management procedures
- Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
- Create and deploy Risk Management Plan / Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
- Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls.
Represent department at Quality Review Board and Change Review Board meetings
ERFORDERLICHES PROFIL :
- BS degree in Life Sciences discipline or mechanical engineering, Graduate degree preferred
- Min. 2 years experience and hands on expertise in device quality or device development
- Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
- Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
- Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
- Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
- Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
- Very motivated and willing to perform tasks with varying complexity
- Fluent in English, German is a plus
Application process
Interested? You can find more information here :
19 ore fa