QA Manager Combination Product and Device

Vor 3 Tagen

Basel, Schweiz GITR Vollzeit

**INTRODUCTION**:
As a preferred supplier for Roche Basel we are looking for an individual as

**QA Manager Combination Product and Device**:

- with a one year contract and with the possibility to extension. The earliest start date is within 2 months. Homeoffice will be possible up to max. 50%.

**ASSIGNMENT DESCRIPTION**:

- 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. first experience in a GMP regulated environment
- Expertise in device quality or device development
- 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
- English speaking, German is a real plus

**Personal requirements**:

- You have to be a teamplayer
- Structured working method
- Solution-oriented work
- Strong persuasive power
- Motivated to learn new process

**Application process**

***
Interested? You can find more information here:

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