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  • Location

    Leiden, Netherlands

  • Job title:

    Qualified Person

  • Sector:

    Biotechnology

  • Job ref:

    45924

  • 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.

The Quality Assurance department stands for consistently ensuring the delivery of safe, cost-effective and high-quality products for patients in need. This position is opened for the commercial group, providing end-to-end Quality support for the company their biological products. 

Role Description
As a Qualified Person you have strong knowledge of GMP guidelines and Quality Management systems. You ensure that drug substances are manufactured, tested, labeled, packed, released and distributed in compliance with GMP, company guidelines and relevant regulatory authorizations. You will work in close collaboration with other departments. 

Responsibilities

- Review and approve release of Drug Substance lots, including process validation batches and commercial batches
- Acting as a backup QP for clinical products
- Review critical quality documents
- Ensure safety, efficacy and quality of product released
- Approval of High Risk Changes Controls, representing the site in the local change control board

Requirements

-  Master's Degree in a relevant field, acted as a Qualified Person in the Pharmaceutical industry
- Proven knowledge of the (bio-)pharmaceutical industry
- At least 6 years' of experience in a GMP regulated environment
- Good negotiation skills with customer-centered attitude
- Fluent in English and Dutch 
 

Other Information
The following requirements are preferred:
- Knowledge of TrackWise and SAP systems
- Experience in data analytics and data visualization
- Proficiency in Lean or Six Sigma

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