The Chemelot Institute for Science and Technology (Chemelot InSciTe) is a public private partnership founded by the University of Maastricht, Maastricht University Medical Center, the Technical University of Eindhoven, DSM and co-financed by the Province of Limburg. InSciTe has two innovation and development programs: biomedical and biobased materials.
Within the biomedical program InSciTe runs a biomedical facility with open R&D labs, project rooms and cleanrooms. Here, we have created an ISO 13485:2016 certified work-learning environment where top scientists from the InSciTe biomedical projects as well as start-ups develop, test and produce biomedical materials solutions for patients and market.
For more information: www.chemelot-inscite.com
Position in the organisation
The QA Manager is a member of the InSciTe team and works side-by-side with the Biomedical Facility Manager. The QA Manager leads and guides the quality team and functionally reports to the Responsible Person.
Description of Role
The Quality Assurance Manager (QA) is responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable ISO guidelines and all existing GMP standards in the area of responsibility.
The InSciTe organization is a small and lean team of professionals that are motivated to bring more or less proven concepts further in the value chain.
As a Quality Assurance Manager you will be responsiblie for:
– Leading and advising the multi-disciplinary project teams in regulatory processes
– Hands-on support for the project teams in quality processes, e.g. FMEA,
– Document (Control) Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplierqualifications etc.) including documentation;
– Monitor compliance with all applicable GMP and safety standards;
– Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests);
– Handle, distribute and archive controlled documents;
– Heads the Quality Circle;
– Support internal/external audits and quality training.
Knowledge and experience
– Relevant degree in biomedical related area or at least 3-5 years of expertise in
– QA/RA in the field of biomedical applications;
– Knowledge of GMP;
– Experience with setting up and/or restructuring Quality Management Systems;
– Experience in and knowledge of quality systems and ISO certification (e.g. ISO 13485, MDD, ISO 9001) in the biomedical/regenerative medicine field
– Excellent command of English, spoken and written.
– Accurate, structured and precise
– Independent and self-organized
– Flexible: adapts easily to new circumstances
– Stress resistant
– Likes to teach and train people
– Able to manage multiple priorities with good follow through
– Positively contributing to a good working atmosphere within the team, team player
– Good communication skills
A challenging job with lots of variety and responsibilities within QA/RA in an open innovation setting.
This is in principle a full time position (40 hours per week). Any part-time interpretation based on at least 4 days a week is negotiable.
For more information you can contact Robin Bisschoff via +31 6 14 79 56 47.
Please apply via the “Apply” button. We are looking forward to receiving your application!
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