Biotech and Agricultural Engineering Medical and Healthcare Other Science and Tech
1 - 2 Years
Leiden | Qualified Person | QP | Quality Assurance | Pharma | Commercial Drug Substance
Your new role
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 a commercial and an NPD (New Product Development) & Launch branch. This position will be placed within the Commercial group. QA OCP (Operational Commercial Products) provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation, and batch disposition) for our commercial biological products. These products are released and distributed in a worldwide market. You will be working in a quick evolving and dynamic environment, with a continuous focus on improvements and support to several projects on product/process development to increase capacity.
The Position: At QA OCP (Operational Commercial Products), we are currently looking for a Qualified Person, with strong knowledge of both GMP guidelines and Quality Management systems, to join our team. As EU-Qualified Person API, you ensure that drug substances are manufactured, tested, labeled, packed, released, and distributed in compliance with GMP, J&J Guidelines, and relevant regulatory authorizations. You will work in close collaboration with other departments (Operations, Tech Ops, Lab, Engineering). In this position, you report into the Quality Assurance OCP department.
What you'll need to succeed
Master’s degree in Biochemistry, Biology, Pharmaceutical degree or relevant education. Acted as QP in the Pharmaceutical industry.
Proven knowledge of the biotechnological/pharmaceutical industry and at least 6 years of experience in a GMP regulated environment (manufacturing, QA, and/or QC)
Excellent analytical abilities, eye for details
Empowered professionals who can make well-motivated pragmatic decisions on their own.
Ability to drive collaboration in a fast-paced environment
Good negotiation/influence skills with customer-centered attitude
You have excellent proficiency in English and Dutch both in word and in writing.
Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
Trackwise, SAP systems
Experience in data analytics and data visualization
Proficiency in Lean or Six Sigma
Your new company
The Company: Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicine. 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. Janssen Biologics Leiden Operations delivers key commercial Biotherapeutic products (API) like Remicade, Simponi, and Stelara. Janssen Biologics is part of the Johnson & Johnson family of companies.
What you'll get in return
It is a temporary contract for 6-12 months which can be on freelance basis (ZZP) or secondment via Hays.
You are expected to be on site for a minimum of 2 days a week. The other 3 days you can work remotely.
Immediate availability is important. (preferred starting date is mid-April)
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1041804