Sr. Quality Assurance, CSC Associate

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Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is looking for a senior QA associate to strengthen the Product Quality Management - Clinical Supply Quality team! We are a motivated team guaranteeing the quality oversight over multiple and complex clinical supply chains for innovative products in the Janssen portfolio covering small and large molecules, vaccines, and advanced therapies medicinal products (ATMP).

One of our main responsibilities is the release and certification of investigational medicinal products used in worldwide clinical trials so that patient safety & compliance with applicable regulations are warranted.

We are continuously adapting and improving our quality processes to accommodate the needs of the compounds with the ultimate goal of providing hope in a box to our patients.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our innovative products? Apply today for this exciting opportunity!

As a senior QA associate you will:



* Perform batch release for clinical trial material in scope of the IMP license of Janssen R&D, a division of Janssen Pharmaceutica NV.


* closely collaborate with CSC groups and global departments such as ECSQ (External Clinical Supply Quality), PQM (Product Quality Management) and PES (Partnership & External Supply) to obtain all vital inputs for a timely release and QP certification in support of a reliable supply chain.


* Represent QA Clinical Supply Chain (CSC) in different teams.

Ensure the needs of clinical supply quality are embedded from the start of clinical trial execution.


* Act as an expert resource in assessing and maintaining quality and compliance levels.

Thereby ensuring compliance with the GMP and GDP requirements, the clinical trial directive/regulation and other legislation in a clinical trial environment.

Support the operational departments by providing coaching and/or training.


* Ensure quality oversight of the operational activities by QA approval of GMP documentation, including quality agreements, and support/participation in the different quality review meetings.


* Ensure that deviations/complaints are timely and accurately investigated such that the internal and external ...