We are looking for 2 specialists: one candidate needs to have an Analytical background, one candidate has a background in Manufacturing and/or Validation Processes.
As an enthusiastic QA Specialist NPD & Launch you will provide independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. Hereto you work in close collaboration with other departments (Operations, One Lab, Engineering, Vaccines Launch Facility and Development Departments). 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
Our client is part of an international company, and develops and manufactures biologicals aiming to treat diseases in the field of cardiology, immunology and oncology.
The Quality Assurance Department is responsible 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.
As the QA Specialist you will be working 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 new biological products and vaccines that will be used in Clinical Studies to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment.
Functie-eisenYou are eligible for the job with a Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education and 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
- Ability to drive collaboration in a fast-paced environment
- 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
You have strong knowledge of both cGMP guidelines and Quality Management systems, as well as a strong sense of urgency and a passionate commitment to getting things done.
Employment for 32 – 40 (preferred) hours per week starting at an innovative company. 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 firstname.lastname@example.org or 040 - 7999 010
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Please tell us who you are and what motivates you! Send us your using the application button on this website. Closing date is 21 August 2020.