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  • Location

    Leiden, Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

    Biotechnology

  • Job ref:

    45883

  • Start Date:

    2021-04-12

The Company
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for human health.

Role Description
This team is responsible for overseeing and supporting the quality systems, projects, manufacturing activities and facilities of different sites and external collaborations. As a Quality Assurance Specialist you are proactive and willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

Responsibilities

- Ensuring that clinical drug substance and associated manufacturing and testing activities comply with cGMP requirement, policies and procedures
- Review and disposition of drug substance batches for clinical release
- QA Oversight for drug substance manufacturing and laboratory operations
- Issue and escalation management, CAPA design and root cause analysis support 
- Review and approve cGMP documentation (SOP's, protocols and technical reports)

Requirements

-  Master's Degree in Science or Engineering 
- At least 6 years' of QA experience
- 2 years' of experience in product disposition processes and requirements 
- cGMP manufacturing and testing in biotechnology industry preferable in vaccines
- Solid knowledge on EU and global regulations, cGMP standards and ICH guidelines

 

Other Information
Within this role you will work in a multidisciplinary and dynamic team, looking for a candidate with excellent communication skills and can work independently and organized. 

Contact Us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804