GMP compliance specialist ATP

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 Documentation

Job Category:
Professional

All Job Posting Locations:
Leiden, South Holland, Netherlands

Job Description:

J&J Innovative Medicine is recruiting for Data & Systems engineer, located in Leiden.

Job Description GMP compliance specialist

The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular and pulmonary hypertension.

The Advanced Therapies Pilot Plant (ATP) in Leiden produces clinical trial material for advanced therapies, a novel class of medical products that uses cell and gene therapies to treat diseases and have the potential to cure diseases when no treatment is available.

It's a very exciting field, as no established manufacturing platforms exist for these products, which means that new processes need to be developed to ensure efficient production of high-quality GMP material!

The ATP is a very active pilot plant, with 3 full GMP productions streets, making 5 different product types, and a 4th street with a Drug product fill line being created - making it a true end-to-end pilot plant! The ATP teams also work in close collaboration with the process development teams to enable fast delivery of the products for clinical trials.

We are recruiting a GMP compliance specialist to join our teams.

We are seeking a highly motivated and independent individual who will be very involved in all aspects of GMP compliance & EHS in the plant, from introducing new standards, to maintaining current standards and identifying and implementing improvements.

Key Responsibilities:


* Ensuring high quality and compliance standards by execution of nonconformances, CAPAs, corrections, through initiating and leading change controls and in coordinating, reviewing, coaching and training of employees in performing investigations. 


* Authoring, coordinating and reviewing documentation, both for the implementation of new standards and processes and for updating existing documentation.


* Actively participate in the department in both EHS and compliance associated tasks (e.g.

pre audit interactive trainings, GEMBA, self-inspection follow up) to ensure compliance level is maintained and supports in audits.  


* Recommending and developing improvements to processes and procedures, re...