QA Release Responsible / Site QP Delegate

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:
Olen, Antwerp, Belgium

Job Description:

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

We are currently looking for a QA release responsible / site QP delegate who has a passion for quality and loves to operate in a very dynamic pharmaceutical production environment.

We are looking for a quality expert who likes to work in an international environment and is connecting easily with our different business partners.

Janssen Pharmaceutica Olen is part of the Janssen Pharmaceutica N.V.

legal entity.

At the J&J Innovative Medicine Supply chain Olen site, pellets are manufactured and released.

In this role, you will be located at the Olen site, and you will be reporting to the QA operations manager of Liquids & Creams, CWA/Formulation, Gogu warehouse and Olen.

The QA department ensures that all GMP activities of manufacturing, packaging and release are carried out as required by GMP legislation.

What you'll do:

Your role as a QA release responsible/site QP delegate for the Olen site, you ensure that all GMP activities of manufacturing, packaging, labelling, testing, release and distribution of products are carried out as required by GMP legislation.

You are responsible for the daily quality operations within the Olen production area and take up additional responsibilities within the QA liquids & creams team:


* Batch release of the products.


* Ensure that deviations, CAPAs, Change Controls and trend reports are timely and properly investigated by providing quality and compliance expertise.


* Assure compliance with the marketing authorization and Good Manufacturing Practices.


* Act as spokesperson during Health Authority inspections and customer audits.


* Perform check rounds and periodic witnessing of operational processes.


* Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results and act as Qua...