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  • Location

    Leiden, Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

    Biotechnology

  • Job ref:

    45803

  • Start Date:

    2021-04-01

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 their health.

Role Description
Within the Quality Assurance department you will collaborate in a matrix environment to drive handling of quality data. For their internal audit program you will take on the role of lead auditor or co-auditor depending on your qualifications and capabilities. 
The Quality Assurance department is forward looking, working on improving processes, being customer focused and supports the need for speed. You will work in a multidisciplinary and dynamic team to support and drive quality.

Responsibilities

- Maintain the Site Master File
- Asses site risks and maintain and improve the Site Risk Register
- Support and execute quality investigations (CAPA Management) and change controls in a GMP environment 
- Representing the Quality department when needed

Requirements

-  Master in a scientific discipline such as Pharmacy or Bio-Pharmaceutical science
- Experience with working and handling quality data dashboarding (Tableau would be an asset)
- Knowledge of TrackWise system and Risk management such as RCA, CAPA management and Change Control Process
- Experience with training delivery and curriculum management
- Lead auditor or experienced with being a co-auditor in a GMP environment 
- Fluent in English, Dutch is an advantage

Other Information
Previous experience working in a GMP environment preferably in vaccines is a pre.

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