QA Documentation Specialist – I

Amsterdam | Deviations | GMP | Aseptic Techniques | QA | Documentation | Corrective actions |

Your new company

Our client 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, their team is executing on a strategy to bring life‑saving therapies to patients.
With their brand‑new production site in Hoofddorp, they are dreaming big. Now you can get the chance to be a part of this journey.

Your new role

In your new role, you will be responsible for the verification of controlled issued batch documents and label packages, including final product labels per cGMP, as requested by operational departments.
• Responsible for timely consumption of consumables/GMP materials used or informing the responsible person.
• Ensure accuracy and completeness of QA issued documents and controlled logbooks
• Identify and escalate compliance gaps across the controlled issuance process.
• Execute strategic initiatives to improve the controlled issuance process.
• Support/investigate deviations on controlled issuance process and develop effective corrective action plans.
• Demonstrate attention to detail and ability to consistently deliver accurate output in routine accountabilities.
• Demonstrates the ability to clearly and concisely present/ explain document issuance operation and its requirements / guidelines to multiple internal audiences.
• Demonstrate the ability to cross train colleagues and customers


What you'll need to succeed

  • HBO or WO level education

  • 2+ years experience of document management in a regulated environment • Advanced level of English communication

  • The ability to communicate effectively with stakeholders and peers.

  • Positive demeanour.

  • Technical knowledge of GMP.

  • The ability to prioritise deadlines.


What you'll get in return

Hays Detaching – | This is a project that will start with a contract for 12 months through Hays. An extension to stay within the department is anticipated. In this position, you will get a competitive salary (starting from € 60,000) 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.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.


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Summary

Job type
Temporary
Industry
Manufacturing & Production
Location
Amsterdam
Specialism
Life Sciences
Pay
Competitive salary based on experience
Ref:
1049791

Talk to a consultant

Talk to Ife Opeoluwa, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11

Telephone: 0683399042

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