Werken bij REEF - Senior Quality Officer
You will work with a department responsible for oversight of departments involved in biotech production processes. The department's mission is to achieve local and global quality and compliance excellence within the processes that ensure patient safety. They ensure that the biotech production departments are working according to GMP procedures.
You will coach, guide and enthusiasm the biotech staff to harmonize and implement new guidelines and structure of the Quality Management System (QMS). You will be responsible for assisting the department with implementation of the QMS, to integrate the QMS requirements and structure into the local QMS and in parallel you will pepare a lean QMS. You will also be responsible for the technical and/or utilities part.
Furthermore, you will proactively assist sub-system owners within the organization to harmonize local instructions with global requirements and facilitate and guide QMS restructuring.
- You have a HBO+/Academic level with engineering background (HTS).
- You have at least 3 years working experience in a quality systems position, preferably within the pharmaceutical industry, with experience in project and change management.
- You have good knowledge and experience with QMS development and governance, GMP and ICH guidelines ( ICH q7-8-9-10 ).
- Also you have well developed skills in Microsoft Word an Visio.
- Furthermore you control the English and Dutch language, written and spoken.
As a person you are creative, innovative, independent, self starting and proactive. Also you are a team player with good communication, negotioting and advice giving skills.
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