At QA NPD & Launch, we are currently looking for a QA Specialist, with strong knowledge of both cGMP guidelines and Quality Management systems, to join our team. As an enthusiastic QA Specialist NPD & Launch with a strong sense of urgency and a passionate commitment to getting things done, you will provide independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The QA Specialist works in close collaboration with other departments (Operations, One Lab, Engineering, Vaccines Launch Facility and Development Departments). In this position you report to Sr Manager QA NPD & Launch and will work together with QA officers and QA Associates.
Day to Day Responsibilities:
- Participate as Core Team Member in New Product Introduction projects
- Represent QA in Engineering projects related to the manufacture of Biological /Vaccine products OR
- Provide QA support to the introduction and release of (new) Raw Materials
- Provide QA support technology and/or Analytical Transfer and improvement of existing manufacturing / analytical processes
- Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations
- Provide Quality support for the development of appropriate Corrective and Preventative actions
- Participate in risk assessments to ensure compliance or quality is not jeopardized
- Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory
- Provide review and approval of document changes and change controls
- Lead or act as member for local or global capacity/quality projects
- Optimize current and identify new ways of process and quality monitoring
Janssen Biologics B.V. 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. Janssen Biologics is part of the Johnson & Johnson family of companies.
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 NPD & Launch group. QA NPD & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for our new biological products and vaccines. These products will be used in Clinical Studies to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment.
We are looking for an Quality Assurance Specialist!
Functie-eisenYou are suitable for the job when you have the following profile:
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
- Ability to drive collaboration in a fast-paced environment
- Proven knowledge of the biotechnological/pharmaceutical industry and 5 years of experience in a GMP regulated environment (manufacturing, QA and/or QC)
- Knowledge and Experience in vaccines is a pre
- Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is a must
- Experience in Biologics (Manufacturing, Engineering OR Analytical) preferred
- Experience in data analytics and data visualization preferred
- Proficiency in Lean or Six Sigma preferred
Further you have good communications skills in English, you have excellent analytical abilities, eye for details, good investigative abilities, empowered professional who can make well motivated pragmatic decisions on their own.
A contract with Modis Life Sciences with an exciting opportunity in a leading company in the pharmaceutical industry. You will be part of a dynamic and accomplished team
You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.
If you wish to receive more information first, please contact us on email@example.com or contact one of our Recruitment Consultants:
Barbara Flaton on 06-2266 4285
Lars Wijnands on 06-1333 9633
I want to apply now
Please tell us who you are and what motivates you! Send us your using the application button on this website. Closing date is 24 July 2020.