QA Manager Combination Product and Device
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QA Manager Combination Product and Device (m/f/d), BaselClient: FLEXSIS
Location: Basel
Job Category: Other
Job Reference: 3607a2a3f125
Job Views: 5
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description: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.
Responsibilities:- 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.
- 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.
Interested? You can find more information here:
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