QA Documentation Specialist

Hoofddorp | Quality Assurance | Documentation | Document Management | Deviations | GMP | Audit | 1044806

Your new role
As a QA Documentation Specialist you will be responsible for the controlled issuance process and ensuring accuracy and completeness of QA issued documents. You will be responsible for controlled issuance of logbooks, batch document and label packages, including Final product labels per cGMP, as requested by operational departments. You will identify and escalate compliance gaps across the controlled issuance process. Additionally, you will execute strategic initiatives to improve the controlled issuance process. You will also support or investigate deviations on controlled issuance process and develop effective corrective action plans. In addition to the responsibilities mentioned, you will support audits (internal, external). These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

What you'll need to succeed
In order to be a successful a QA Documentation Specialist, you need to have extensive technical GMP knowledge. You need to be able to demonstrate the ability to clearly and concisely present/ explain document issuance operation and its requirements /guidelines to multiple internal audiences.Hence, it is important for you to have excellent communication skills, to effectively communicate with stakeholders and senior colleagues and peers.

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.

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 (starting at €2800) and your travel expenses are covered. You will also receive additional compensation for working in shifts.

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. #1044806
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Job Type
Life Sciences

Talk to a consultant

Talk to Ewa Tran, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telephone: 0643452976