Challenging QA position at the New Product Development & Launch branch at our client Janssen Biologics Manufacturing in Leiden. In this role you will play an active role in vaccine developemnt for Corona Vaccine.
Job Description
New Product Development & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for 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. As QA specialist you have diverse responsibilities in the team. Specifically
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;
Requirements
Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education;
Experience with Vaccines is considerd a big advantage;
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;
Excellent analytical abilities, eye for details;
Empowered professional who 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 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;
Benefits
Contract: 1 year through Oxford Global Resources, realistic long term perspective;
Salary: €3500 - €5500- gross monthly based on level of experience;
Hours full-time preferred 32h discussable;
Holidays: 25 (+12);
Startdate: Asap;
Vacancy number; 14861
