INT-075695
QA Manager Combination Product and Device (m/f/d)
Basel
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Pharmaceutical / Biotechnology / Chemical
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Permanent full time
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.QA Manager Combination Product and Device (m/f/d)
Description of the mission
- 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
Required profile
- 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: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application. Please upload your CV in English or German only, along with your degree certificate and latest reference letter.
Your contact
- home FLEXSIS - IT RECRUITMENT
- personJie Zhu
- quick_reference_allReference: INT-075695
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