We are looking for an enthusiastic QA Specialist with a strong sense of urgency and a passionate to getting things done. We are currently looking for a QA Specialist with strong knowledge of both cGMP guidelines and Quality Management systems.
Job description
As a QA Specialist you will work in close collaboration with other departments (Operations, Lab, Engineering, Vaccines Launch Facility and Development Departments). You will provides end-to-end Quality support
- non-conformance management,
- CAPA,
- change controls
- validation and batch disposition for new biological products / vaccines.
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 monitoringSupport in
Profile
- BSc or MSc in the fields Biochemistry, Life Science or similar (Phd or MBA is considered overqualified for this position
- Proven knowledge of the biotechnological/pharmaceutical industry
- At least 5 years of experience in a GMP regulated environment (not necessarily QA)
- General knowledge of vaccines is considered a great plus
- Excellent analytical abilities, eye for details.
- Excellent communication skills, and a team player attitude
- Experience in data analytics and data visualizationYou have an excellent proficiency in English both in word and in writing. Dutch is a pre.
Terms of employment
- Employment: temporary contract with prospect of a permanent contract
- Salary indication: from € 3500 to € 5000
- Working hours: 40 hours per week (part-time can be discussed)
- Location: Leiden region
Vacancy number: 15765
