Quality Systems Senior Associate
Locations: Beerse, Belgium
Functions: Quality Systems
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Requisition ID: 1905758063W
Janssen Pharmaceutica NV is recruiting for a Senior Quality Systems Associate, located in Beerse, Belgium.
The Quality Systems group in Beerse is part of the Quality organization of the Janssen Supply Chain and is responsible to ensure compliance of the different quality processes and systems within JSC and DPDS Beerse, Belgium.
You are Subject Matter Expert related to the different quality processes & systems (such as CAPA, Change Control, Internal audit program, Annual Product Review, …) within JSC and DPDS Beerse and from this expertise you are responsible for:
* the management of the Quality Systems team
* the measurement and oversight of the quality process performances in the entire organization
* the training and support of the business in the execution of the different quality processes/systems
* leading quality improvement projects related to the Quality processes/systems taken the business needs into account
* the active participation in global projects for which you are defined as process owner
* the coordination of inspection preparations and acting as spokesperson for the Quality processes during inspections
* the contact person for the APR managed services including the review and approval of Annual Product Review reports (APR)
Education & experience
* Master degree in technical / chemical / pharmaceutical area or equivalent through experience.
* Working experience in regulatory controlled environment: 21 CFR Parts 210, 211; EU Directive 2003/94/EC and annexes; Eudralex Volume 4 GMP guidelines and annexes.
* Previous experience in a QS or QA function is preferred.
* Demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks.
* Excellent verbal and written communication skills both in Dutch and English
* Collaboration and teaming skills
* Focused on solutions
* Strong result and quality mindset
* Strong ownership and responsibility
* Persuasive and credible to act as subject matter expert during internal and external regulatory inspections
* Influencing and negotiation skills
* Mindset for innovation and optimization.
Janssen Pharmaceutica N.V. (7555)