QA Manager Combination Product and Device
Posted on Sep 23, 2020 by ITech Consult
QA Manager Combination Product and Device- chemical/cGMPs/ Six Sigma/English/German
For our customer a big pharmaceutical company in Basel we are looking for a QA Manager Combination Product and Device
The Quality Project Manager position will provide in-depth Device Quality expertise for drug delivery systems (under development or commercial) to ensure compliance with applicable standards and regulations. The position will be the quality support for Device Development project teams.
Tasks & 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 Chemical/mechanical engineering, Graduate degree preferred
. 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
. English speaking, German is a real plus.
* You have to be a teamplayer
. Structured working method
. Solution-oriented work
. Strong persuasive power
. Motivated to learn new process
07:00am - 12:00am and 01:00pm - 06:00pm
Reference No.: 919638SGR
Role: QA Manager Combination Product and Device
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.