Yacht Life Sciences has a vacancy for a Quality Assurance (QA) Officer to work for Janssen Biologics in Leiden and take part in their COVID-19 vaccine project.
For the QA New Product Development (NPD) & Launch department, we are currently looking for a QA Officer, with strong knowledge of both cGMP guidelines and Quality Management systems. As an enthusiastic QA Officer NPD & Launch with a strong sense of urgency and a passionate commitment to getting things done, you will contribute to the Quality support for all New Products quality related topics within the Leiden manufacturing site (i.e. development departments, production facilities and quality control labs).
As a QA Officer you act as a quality expert and applies Quality Systems to create, review and approve GMP documentation as needed for the introduction of New Products at the manufacturing facilities. The QA Officer 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 other QA officers and QA Associates.
Day to Day Responsibilities:
- Draft / Update Standard Operating Procedures, Validation Master Plans, Templates
- Review and approve validation assessments, protocols and reports
- Review and approve analytical method transfer protocols and reports
- Perform batch record review
- Release Raw Materials
- Prepare QP release packages
- Act as trainer for the use of Quality processes
- Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization
- Provide review and approval of document changes and change controls
- Act as member for local or global capacity/quality projects
- Optimize current Quality Processes
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
- Proven knowledge of the biotechnological/pharmaceutical industry and 2 years of working experience in a GMP regulated environment (manufacturing, QA and/or QC)
- Knowledge and experience in vaccines is a pre
- You have an excellent proficiency in English both in word and in writing
- Ability to drive collaboration in a fast-paced environment
- Excellent analytical abilities, eye for details
- Ability to make well motivated pragmatic decisions on their own
- Problem solving
- Good communication, influence and negotiation skills
We offer 3 challenging positions which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is possible). This position is open for freelancers/ ZZP as well.
We will offer a competitive benefits package in line with the seniority of the position (salary between 3500 and 4500 euro gross per 4 week period). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
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.
At Quality Assurance, they 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 their 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.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.