Join to apply for the Pilot Plant Quality and Compliance Lead role at Johnson & Johnson Innovative Medicine
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
Qualifications
* Ph. D. or Master in Chemistry or Chemical Engineering, with 5-10 years of experience in the Pharmaceutical Industry.
* Practical knowledge of cGMP and Q7A.
* Strong team player with previous experience in leading teams.
* Understanding of process safety, operations, process development & engineering.
* Hands‑on experience in pilot or large‑scale manufacturing plants.
* Challenge the status quo and analytical mindset.
* Project management skills.
Responsibilities
* Define what phase appropriate c-GMP means for the API pilot plants in an evolving landscape and how CDS can implement these requirements retaining the flexibility and speed for development activities.
* Initiate and implement projects to keep the compliance level of CDS systems at evolving and required standards. Systems in scope are equipment and systems qualification, data integrity, contamination control, system based compliance, … .
* Act as spokesperson towards the QA organization and take the lead in CDS to prepare audit readiness of the plant.
* Install a live cycle management program to keep our systems in accordance with the actual regulations.
* Serve as SME in GMP requirements for API production and give guidance to the team.
Location
Beerse, Antwerp, Belgium; Geel, Antwerp, Belgium
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