Documentation Specialist I – Quality Systems
Amsterdam | Documentation Specialist | Quality Systems | GMP | QA | Batch documents | 1048510
Your new company
This 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. They have 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 an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, they are dreaming big. Now you can get the chance to be a part of this journey.
Your new role
As a Documentation Specialist in Quality Systems, you will be responsible for the verification of controlled issued logbooks, batch documents and label packages, including final product labels per cGMP, as requested by operational departments. Your responsibilities include but are not limited to:
- Ensuring timely consumption of consumables/GMP materials used or informing the responsible person.
- Ensuring accuracy and completeness of QA issued documents.
- Identifying and escalating compliance gaps across the controlled issuance process.
- Executing strategic initiatives to improve the controlled issuance process
- Support/investigate deviations in the controlled issuance process and develop effective corrective action plans.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
What you'll need to succeed
You will have HBO or WO level education, and 2+ years’ experience of document management in a regulated environment. You have advanced technical knowledge of GMP, and can clearly present/ explain document issuance operations and its requirements to multiple internal audiences. You have an advanced level of English communication. You are positive, able to prioritise and meet deadlines. You have good attention to detail and deliver accurate output in routine accountabilities. You demonstrate the ability to communicate effectively with stakeholders, senior colleagues and peers.
What you'll get in return
Hays Detachering | This is maternity cover and has a contract for 10 months through Hays. Extension will be based on business needs. In this position, you will get a competitive salary of €56,970 and your travel expenses are covered. Visa sponsorship is not possible in this position.
What you need to do now
If you are interested in this role as Documentation Specialist I – Quality Systems, 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 about your career.
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Overzicht
- Contractvorm
- Tijdelijk
- Branche
- Wetenschap, Research & Development
- Locatie
- Hoofddorp
- Vakgebied
- Life Sciences
- Salaris
- Competitive salary of €56,970 and your travel expenses are covered
- Referentie:
- 1048510
Spreek met een consultant
Spreek met Sarah Maher, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11
Telefoonnummer: +31645185871
JOB_52729201048510