The Department: At Janssen Biologics B.V., a multinational pharmaceutical company, we are currently looking for a QA Associate, with strong knowledge of both cGMP guidelines and Quality Management systems, to join our team. As an enthusiastic QA Associate with a strong sense of urgency and a passionate commitment to getting things done, you will be the primary point of contact for all quality related issues within the Leiden manufacturing site (i.e. production facility and quality control labs). You will provide independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. In this position you will work together in a team of 6 QA Associates, within a multidisciplinary QA department.
QA Operations Commercial Products is a dedicated team of professionals responsible for managing the comprehensive elements of the quality systems (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for our pharmaceutical products in the Leiden production facility. We are focused on maintaining and improving end-to-end quality & compliance, following trends in the network to adopt new technologies and having a quality culture that is embraced by the organization. As Quality, we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need.
- 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
- Support (Global) escalation of issues, which have potential impact on the delivery of products to our patients
- Participate in risk assessments to ensure compliance or quality is not jeopardized
- Act as trainer for the use of Quality processes
- Be actively involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing 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
- 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
- Excellent analytical abilities, eye for details.
- Empowered professional whom can make well motivated pragmatic decisions on their own.
- You have an excellent proficiency in English both in word and in writing. Dutch is a pre.
- Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
- Preferred knowledge:
- Trackwise, SAP systems
- Experience in data analytics and data visualization
- Proficiency in Lean or Six Sigma
Janssen Biologics (7266)