QA Manager Combination Product and Device m/f/d)
QA Manager Combination Product and Device m/f/d) – device quality / device development / Deplyig Design Control / cGMPs / QSR; MDR; ISO13485/ Six Sigma / DMAIC / English /German
Project:
For our customer a big pharmaceutical company in Basel we are looking for QA Manager Combination Product and Device (m/f/d).
Background:
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 a support of the Quality SPOC (single point of contact) for the Device Development and Device Industrialization project team.
The perfect candidate has min. a bachelors degree in a life sciences discipline or mechanical engineering and min first experience in a GMP regulated environment. Expertise in device quality or device development is required, also demonstrated capability of applying risk management concepts and tools, and deploying Design Control.
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
Must Haves:
* 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
* 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
Reference Nr.: 923737SDA
Role: QA Manager Combination Product and Device (m/f/d)
Industrie: Pharma
Workplace: Basel (Home Office: max. 2 days per week)
Pensum: : 80 – 100%
Start : ASAP (Latest start Date: 01.02.2025)
Duration: unlimited
Deadline: 23/10/2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.
