Quality Assurance Specialist

Imagine your next role as a Quality Assurance Specialist where you will be a team member with the responsibility to ensure project changes are implemented according to cGMP guidelines and quality management systems.

About the department 

As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost-effective, and high-quality products for the patients in need. The QA department has an OCP (Operational Commercial Products) and an NPD (New Product Development) & Launch branch. Both teams provide end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation, and batch disposition) for commercial and clinical products.

In addition to the base business activities for our commercial products, the company also has a large project portfolio to introduce new products, implement new technologies, improve our processes, perform ELM, and increase our capacity to be able to deliver future demands.

Responsibilities

• Review and approve change controls, validation protocols and reports, validation assessments, URS, and applicable lifecycle documentation.

• Track and monitor the progress of changes to anticipate, flag, and prevent any delays in change implementation.

• Act as a quality expert and applies our Quality Systems to create, review, and approve GMP documentation. 

• Work in close collaboration with other departments (Operations, QC, Engineering, RA, etc.).

To be successful in this role you have to have:

• BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;

• 5 or more years of QA experience in pharmaceutical or related industry; 

• Up-to-date knowledge of current GMP regulations;

• Experience in Change control and all documenting related activities;

• Experience with validation;

• Experience with sterile manufacturing is preferable;

• Experience with documentation systems like Trackwise, and True Vault is preferable;

• Experience with Systems like Delta-V, Scada, PAI, or MES is a pre;

• Experience in Computer system validation is a pre;

• Good communicative and advisory skills in English(verbal and written), a good Dutch language level is an advantage;

• Able to work independently as well as in a team.  

benefits

This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months. 

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen 

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl/janssen-nederland/biologics-leiden

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 in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every 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”!