Documentation Specialist

Amsterdam |GMP | Quality Systems | HBO + | Documentation | CAPAs & Deviations | 1048723

Your new 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 an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.


Your new role

As a Documentation Specialist you will have a number of different responsibilities to ensure the accuracy and completeness of QA issued documents. You will also be responsible for the verification of controlled-issued batch documents and label packages, including final product labels per cGMP. You’ll be responsible for the verification of controlled issued logbooks and identifying and escalating compliance gaps across the controlled issuance process. Other activities will include executing strategic initiatives to improve the controlled issue process and support / investigate deviations on con the process and develop effective corrective actions plans. In terms of GMP, there will be a big focus on explaining the document issuance operation and an ability to cross train colleagues and customers.


What you'll need to succeed

You have a HBO level degree in Life Science with 2+ years of experience on document management in a pharmaceutical regulated environment and excellent communication skills. You have excellent organisational skills and demonstrate the ability to prioritize and meet deadlines with an accurate attention to detail. You have a positive demeaner and you enjoy working as part of a team in a fast paced environment. You also enjoy working in a routine based environment.


What you'll get in return

Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is highly anticipated. At this position, you will get a competitive salary and your travel expenses are covered. The salary range for this role is between €51,760 - €58,230 based on experience. Some flexibility to work on weekends as required in rotation which is compensated by shift allowance. Candidates who require visa sponsorship cannot be considered for this position.


What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


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Overzicht

Contractvorm
Tijdelijk
Branche
Industrieel & Productie
Locatie
Amsterdam
Vakgebied
Life Sciences
Salaris
€51,760 - €58,230 based on experience + travel expenses are covered
Referentie:
1048898

Spreek met een consultant

Spreek met Eibhlin Hanlon, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11

Telefoonnummer: 0615868143

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