Overview
Join to apply for the Pilot Plant Quality and Compliance Lead role at Johnson & Johnson Innovative Medicine.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Location
Beerse, Geel, Antwerp, Belgium
Responsibilities / Your Activities
* Defines what phase appropriate c-GMPs means for the API pilot plants in an evolving landscape and how CDS can implement these requirements while retaining flexibility and speed for development activities.
* Initiates and implements projects to maintain the compliance level of CDS systems at evolving and required standards. Systems in scope include equipment and systems qualification, data integrity, contamination control, system-based compliance, etc.
* Acts as the spokesperson towards the QA organization and leads CDS to prepare audit readiness of the plant.
* Installs a live cycle management program to keep our systems in accordance with current regulations.
* Serves as SME in GMP requirements for API production and provides guidance to the team.
Qualifications, Experience and Skills
* 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
* Challenging the status quo with an analytical mindset
* Project management skills
Job Details
* Job Function: R&D Product Development
* Job Sub Function: R&D Process Engineering
* Job Category: People Leader
* Employment Type: Full-time
About the Company
Johnson & Johnson Innovative Medicine is focused on health innovation across medicines and medtech, aiming to deliver breakthroughs that improve health outcomes.
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