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QA Specialist Operations


Amsterdam | QA Specialist Operations | GMP | CAPA | Change Control | Deviations | Aseptic Manufacturing

Het bedrijf / The company

Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago.

With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, Kite is dreaming big. Now you can get the chance to be a part of this journey.

De functie / The role

As QA Specialist, you will work within the Quality team, supporting Kite"s efforts in this exciting new area of cancer immunotherapy. You will work cross functionally to assist with the maintenance and execution of a quality system that supports Kite"s rapid expansion of our first commercially marketed cell therapy product in the EU. The position is part of the European Technical Operations team that is located in Amsterdam, the Netherlands and will report to the QA Manager EU.

Your responsibilities include, but are not limited to, reviewing batch-related documentation, product release issues, assisting the Kite QP and overseeing packaging/shipping processes within the European Union. Furthermore, you ensure that all product-related deviations and CAPA"s are initiated, investigated and resolved. Finally, you liaise with other Kite manufacturing sites for smooth batch release for the EU and you contribute for further implementation of Quality in the Netherlands sites.

Het profiel / Your profile

For this position, you need a Bachelor"s degree in a biological related field and a minimum of 5 years of experience in QA and/or Manufacturing in a pharmaceutical or biotechnological environment. You have working experience with CAPA"s, deviations and Change Controls in a GMP regulated environment. You have good spoken and written skills in English, are able to follow and change SOP"s and, finally, you have ideally knowledge of aseptic manufacturing processes.

Het aanbod / The offer

Hays Detachering | This is a project that will start with a contract for 7 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€3000 - €5000) based on previous experiences and your travel expenses are covered.

Tenslotte ..... / Finally ....

If you are interested in this role as QA Specialist, click "Apply now" to send an up-to-date CV, or give us a call! Is this job isn"t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

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Kite Pharma

Geplaatst op FMF: 12 september 2019

Branche: Farma & Biotech
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc
Werkervaring: 2-5 jaar, 5-10 jaar