Senior Quality Assurance Associate

At Johnson & Johnson, we believe health is everything.

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:

Within Johnson & Johnson Innovative Medicine, we are recruiting a Senior QA Associate for Investigational Medicinal Products (IMP) as member of our Clinical Supply Quality (CSQ) Operations Beerse drug product team based in Belgium.

Our department CSQ is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.

In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide.

R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine.

As Senior QA Associate CSQ Operations Beerse drug product, you will support the clinical release and quality oversight process of IMPs (chemical and biological compounds) used in worldwide clinical trials so that patient safety and compliance with applicable regulations are warranted.

Specifically, within the CSQ Operations Beerse Drug product sub team you will support the sterile clinical manufacturing activities in Beerse and the clinical release activities for Beerse manufactured and external drug products.

 

Key Responsibilities:


* Monitor and ensure compliance with Annex1 of parenteral manufacturing activities.


* Ensure that deviations and complaints are timely and properly investigated and adequate CAPA’s are defined for investigations with potential product quality impact.


* Lead/Drive quality in the organisation: Ensure quality is incorporated in the processes & functions.


* Ensure the operational quality performance by participating in different quality review meetings.


* Ensure that all changes that may have an impact on quality, compliance or registration are evaluated in order to execute adequate control, documentation, validation and qualification.


* Ensure in-depth investigations by providing technical, quality and compliance expertise.


* Take accountability of implementation and execution of different quality system processes.


* Work as One team with Quality and Clinical Supply Chain partners to ensure timel...