QA Specialist

Hoofddorp | QA Specialist | GMP | GLP | FDA | EMA | Quality Systems | Deviation | CAPA | Biopharma | 1045789

Your new role
As a QA Specialist, you will perform a variety of QA activities to ensure compliance with applicable regulatory requirements and company procedures. Other activities will include but are not limited to:
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Review’s facilities & engineering, manufacturing, site supply chain (inbound/outbound/warehouse) and quality control data for materials and logistics with guidance from senior colleagues.
  • Contributes to the Quality on the floor processes, including shopfloor walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and Kite procedures.
  • Provides support to deviation lead/coordinators for deviations investigations and corrective and preventive action (CAPA) relating to the scope of support and contributes to the QA review and approval process of deviations, change controls and CAPA.
  • Identifies and reports deviations from approved processes and procedures to senior colleagues

What you'll need to succeed
To be a successful QA Specialist, you will need a BSc in Life Sciences related industry, with basic knowledge of current GMPs and/or GLPs. At least 2 years of experience in the pharmaceutical or biopharma industry is preferred. Demonstratable knowledge of FDA/EMA standards and quality systems is preferred. The successful candidate should have excellent communication in English both written and verbally alongside good interpersonal skills. Good working knowledge of Microsoft Office is desirable.

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 (€50,000 – €60,000) and your travel expenses are covered.

What you need to do now
If you are interested in this role as QA Specialist, click ‘Apply now’ to send an up-to-date CV, or give Ewa Tran a call on 0643452976. 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.
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Job type
Life Sciences
(€50,000 – €60,000)

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

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