Job Information
J&J Family of Companies Senior Associate QA/Qualified Person (QP) in South Holland, Netherlands
Senior Associate QA/Qualified Person (QP) - 2406192610W
Description
We are looking for an enthusiastic and motivated colleague who will help us to strengthen our Quality Assurance team of Johnson and Johnson Innovative Medicine, somebody who would like to contribute to a high quality organization of the site and J&J.
As the Senior Quality Associate/Qualified Person (QP) you will be responsible for the release of commercial LM products produced at the Leiden site, will support complex investigations into Non Conformances, and with that responsible for the improvement of the overall quality status.
The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.
About the Company: J&J 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), such as rheumatoid arthritis and psoriasis. The department Quality Assurance ensures that quality systems are applied as per GMP standards within J&J Innovative Medicine and is responsible for handling non-conformances, bulk product and intermediate product release and change control. The QA department plays an important role in providing advice on quality topics to all departments of the supply chain.
To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role. The responsibilities & the impact YOU will have:
Act as Qualified Person for Large Molecule products
Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of complex site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
Assist in the preparations and lead during inspections (FDA, EMA etc.) to accomplish a successful audit.
Perform level assessment, review and approval of (deviation related) change controls.
Partner with site colleagues to ensure all site changes and projects are conducted in a compliance to cGMP and company quality requirements.
Assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation.
Act as member in Quality Risk Management and /or root cause investigation sessions.
Qualifications
Minimum education and experience required for the position:
We would love to hear from YOU, if you have the following essential requirements
MSc in bioscience, chemistry, pharmacy or related subject
Registered as Qualified Person
2-4 years Quality Assurance experience in pharmaceutical or related industry
Good communicative, collaboration and advisory skills in English and preferably Dutch (verbal and written)
Up to date knowledge of GMP regulations
Experience with quality investigations, root cause problem solving and quality risk management
Familiarity with PE, LEAN tools, concepts and methodologies is preferable.
This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you’re one of the 1000 people who work here, or you’re considering joining the team, we offer:
Flexible working hours
Your chance to work for a global market leader.
A dynamic and inspiring working environment.
Opportunities to work on exciting projects and assignments
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Biologics (7266)
Job Function Quality Assurance
Req ID: 2406192610W