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QA associate_ PQM QA-CSC

Job Description

Within Johnson & Johnson Innovative Medicine we are recruiting a quality associate for Investigational Medicinal Products (IMP) as member of our QA Clinical Supply Chain (QA CSC) team based in Belgium.

In the 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.

Our department QA CSC is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials.

As QA CSC associate, you will support the clinical release and quality oversight process of IMPs so that patient safety and compliance with applicable regulations are warranted.

The Janssen portfolio is continuously evolving, growing and therefore the QA CSC - IMP RCC sub-team is looking for a QA Associate to strengthen the team in execution of the Regulatory Compliance Check and in supporting the implementation of our QA digital roadmap.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our innovative products?

Are you data and document savvy? Do you have continuous improvement mindset? Do you have an affinity with systems? Do you easily connect & is a good team spirit important to you … this position is waiting for you!

Apply today for this exciting opportunity!

As a QA Associate you will:

• Act as the Quality Point of Contact for Regulatory Compliance activities related to the release of Investigational Medical Products used in global clinical trials, this for supplies coming from internal as well as external manufacturers.
• Work as One team with Quality and Clinical Supply Chain partners to ensure timely release and certification of clinical trial material in support of a reliable supply chain.
• Ensure Quality and Compliance operational targets are met.
• Ensure that quality records (e.g., deviation, CAPA, Change Control) are timely and accurately investigated and closed such that the internal and external customer expectations are met.
• Continuously challenge the status quo and support the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
• Develops QA requirements together with the business partners and IT to implement our QA digital roadmap. Responsible for validating the QA User requirements. This includes timely creation and/or review of test scripts and execution of test scripts according to the agreed upon project planning.
• Master data set up is a cornerstone in the QA digital roadmap, you will be responsible to set up, manage and approve master data items. Acts as QA SME and provides first line support in collaboration with DPDS business partners and IT.

Job Qualifications

• University degree, scientific orientation (pharmaceutical, chemical or biological sciences) with at least 2 years experience in the pharmaceutical industry.
• In-depth knowledge in cGMP (domestic & international), J& J policies, standards and procedures.
• Proven ability to work independently while staying connected with stakeholders.
• Understands the business implications regarding quality positions and decisions. Understands the bigger picture.
• Ability to quickly assimilate new technologies and system affinity.
• Ability to translate QA operational requirements into system requirements
• Demonstrated ability to work across organizational boundaries through influencing and partnering. Communication and presentation skills across all levels are important.
• Able to think outside the box and come up with innovative and creative solutions to problems. Open-minded for new ideas and willing to pivot when necessary.
• Able to adjust plans and priorities when circumstances change, to prioritize tasks and manage time effectively, and to show resilience in difficult situations.

Primary Location: Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization: Janssen Pharmaceutica N.V. (7555)

Job: Quality (Eng)

Recruiter:

Hiring Manager: Katrien Moureau

Pay Grade: 25

Referral Eligible