Description
Johnson & Johnson is recruiting a Specialist Quality Assurance in our QA AT Department within Janssen Biologics in Sassenheim.
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/.
Janssen Biologics is working on the establishment of a new Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, as part of the Advanced Therapy (AT) Supply Chain of J&J.
This LVV Business Unit will become a key supplier for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually! The LVV BU is currently in the Tech Transfer, finalizing qualifications, and getting ready for PPQ batches and regulatory site approval, and then starting routine production.
If you get excited about being part of making a global change and are open to the excitement of this new phase, we might be looking for you!
What you will be doing:
- You review and approve validation protocols and reports, CSV documentation, change controls, validation assessments, URS and appliable lifecycle documentation.
- You actively track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.
- You review and approve routine GMP documentation for all components of the Quality system, including Batch Record Review
- You perform the Quality review of Periodic Review reports.
- You perform the Quality assessments of the overview of the validated state of the utilities, equipment and processes, and raise serious quality, compliance and or GMP incidents to Departmental or Project Management.
- You take an active role in continuously improve (Quality) processes, within your own department or by taking the supporting QA Role in inter-department or global improvement initiatives
- Act as a quality representative at routine site meetings and Quality on the Floor or Quality Aseptic Processing Oversight Program activities.
Qualifications
The responsibilities and the impact YOU will have:
- BSc in bioscience, chemistry, pharmacy or related subject with 4 years of experience.
- Or have a Msc in bioscience, chemistry, pharmacy or related subject with 2 years of experience.
We would love to hear from YOU, if you have the following essential requirements:
- Good working knowledge of Quality Management and Pharma regulations (cGMp/ICH/FDA/EMA).
- Empowered professional who can make well motivated pragmatic decisions on their own.
- Ability to drive collaboration in a fast-paced environment.
- Has good communication skills to understand customer needs and has problem solving and analytical capabilities.
- Ability to manage diversity and conflicting viewpoints within the teams they support.
- Demonstrated proficiency in English both in word and in writing.
This is what awaits YOU at J&J:
- Competitive salary and extended benefits package.
- A safe and controlled work environment designed to support high-quality workmanship and compliance with industry standards.
- Comprehensive training with an assigned buddy/mentor.
- Opportunity to work with a dedicated and enthusiastic team.
What type of mark will you make?
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson & Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.
Diversity, Equity & Inclusion at Johnson & Johnson means that “YOU belong”!
For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.