Quality Assurance

Senior Quality Assurance Officer

Location: Leiden

Duration: 6 months contract

Hours: 40h - 32h

Hybrid way of working

Freelancing contract is also possible

Imagine your next role as a Senior Quality Assurance Officer where you will as a quality expert and apply our Quality Systems to create, review, and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Planning, R&D etc.)

About the department

Johnson & Johnson Innovative Medicine is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s).

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. This position will be placed within the NPD group. QA provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation, and batch disposition) for clinical products/process validation batches and supports the advanced therapeutic developments at our site.

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

We are looking for a temporary contractor as backfill to support the base business and where applicable support the projects going on, with the responsibility to assure (project) changes are implemented according to cGMP guidelines and quality management systems.

Main Responsibilities:

• Paper and electronic batch record review
• Raw material release
• Document revisions review and approval
• Review and approve analytical method transfer protocols and reports
• Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation depending on experience.
• Track and monitor the progress of changes to anticipate, flag, and prevent any delays in change implementation.
• Depending on experience supporting master material changes

The ideal candidate for this position should have:

• BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
• 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 documentation systems like Trackwise, True Vault is preferable;
• Good communicative and advisory skills in English, both (verbal and written), understanding of Dutch;
• Able to work independently as well as in a team

benefits

This role offers a competitive hourly rate & a supportive working environment. This contract will run initially for 6 months.

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.

questions

If you would like some additional information about the role please contact: [email protected]

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”.