QA Associate

Amsterdam | QA Associate| GMP | Quality Systems | GMP | Documentation

Your new role
On behalf of Kite Pharma, I am looking for a driven Quality Systems - Document Issuance Specialist. You will work in Quality Assurance team to support the new area of cancer immunotherapy. You will be responsible from preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents. You will work closely with Manufacturing Planning to ensure readiness of documents.
Responsibilities (include but are not limited to):
The Quality Systems Document Issuance Specialist will use Kite’s Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels. You will be accountable for the management of all document issuance and archival processes to support GMP operations. Moreover, you will Issue effective documents including procedures, test methods, specifications and batch documentation. In this role you will Identify and escalate compliance gaps across the document management system and execute strategic initiatives to improve it . Investigating deviations and developing effective corrective action plans for the system will be important part of the job. Generate training to new staff on document management processes and procedures. Lat but not least, you will support internal, external audits, assist in projects when needed.

What you'll need to succeed
You have a strong knowledge of GMP, including GDP, SOPs and quality systems . You have experience in identifying, writing evaluating and closing Deviations and CAPA. You are comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities . Lastly, you have good interpersonal, verbal and written communication skills in English .

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. 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.

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 anticipated. At this position, you will get a competitive salary and your travel expenses are covered.

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.
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Job type
Life Sciences
Closing date
31 Jan 2022

Talk to a consultant

Talk to Anna-Maria Oikonomou, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telephone: 0627068392

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