Quality Engineer

Quality Engineer

Location: Geel   

Duration: 8 months contract (hybrid working)

Hours: 40h

About the department: 

J&J Innovative Medicine Supply Chain Geel  serves as Centre of Excellence for the development and manufacturing of SM-APIs used in treatments that improve the health and lifestyle of people worldwide. The Supply Chain Quality (SCQ) team supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-APIs guaranteeing reliable supplies in compliance with applicable regulations.

The Role:

As Quality Engineer SM-API, you are responsible for the quality oversight and support in order that timely release of an assigned product portfolio of commercial APIs can be met, ensuring compliance with applicable regulations

Main Responsibilities:

• Review and approval of process related investigations and CAPAs, for a small dedicated portfolio of commercial API’s, and also in support of the QA commercial Operations team.

• In dept review and approval of APR and CPV reports

• Ensure that quality records such as Change Controls are timely and properly handled by providing quality, compliance and technical expertise

• Support for smaller optimization projects and tasks within the QA Commercial Operations team

• Establish and maintain strong working relationships with Business and Quality partners.

The ideal candidate for this position should have:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …).

• At least 5 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance. 

• Experience as release responsible is an asset, experience in deviation handling is a must.

• In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes

• Demonstrated ability to work independently while staying connected with key stakeholders.

• Strong analytical thinking skills, solution oriented thinking and able to work in a flexible way under time pressure. Ability to make risk based decision under time pressure.

• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.

• Experience with Quality Systems. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.com/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.