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Consultant analytics/GMP
12-12-2018

#Consultant analytics/GMP

Within our Division Compliance & Validation we are recruiting for a Consultant Analytics /GMP who is ready to enter the world of consultancy. As a Consultant you will work in an ever-changing and challenging environment at our clients in the life sciences industries (e.g. (bio) pharmaceutical industry, medical devices, CMOs). You will act as the expert providing support in diverse development as well as GMP projects, e.g. analytical method development and/or validation, lab process improvements and tech transfer. You will also co-develop new R&D and GMP services for Xendo clients within the life science industry. Based on your affinity and experience with GMP (USA and EU) and your expertise in quality management you contribute to the quality (laboratory) management of our clients.

Usually, the work takes place at the clients’ site and entails working in a team of specialists in which related topics such as active substance, drug product, quality and regulatory aspects are discussed.

Currently our Analytics team is involved in the development of a broader range of services to support our customers in improving their processes. As a new team member you are challenged and invited to bring forward your expert ideas to contribute to these new or improved services.


YOUR PROFILE:


For this role, we are looking for candidates with solid experience (4-6 years) in development (R&D), analytical methods for bioprocessing and/or QC testing of biologicals in the life science industry.
You have a bachelor or a master degree in Life Sciences (e.g. biology, (bio) chemistry, biotechnology, biomedical sciences or pharmacy). It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result- and client oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way.
To be successful as a Consultant Analytics/GMP you also have:


• Hands-on knowledge of bio-analytical methods and preferably microbiological test methods;
• Excellent knowledge of requirements for method validation/transfer within a GMP environment;
• Good understanding in GMP, Annex 15 and regulatory requirements related to analytical method development;
• Knowledge of sterile/aseptic manufacturing and/or environmental monitoring is a pre;
• Excellent in both Dutch and English language;


OUR OFFER:


• a dynamic and varied position in a fast-growing and professional company;
• good terms of employment;
• international projects in (bio-)analytical laboratories t both small and large pharmaceutical companies;
• a comprehensive development program on hard and soft skills.


APPLYING:


If you are interested in this position, we encourage you to send your motivation and CV to us with the form below or by email to .


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