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  • Location

    Leiden, Netherlands

  • Job title:

    QC Stability & Release Associate

  • Sector:

  • Job ref:

    45999

  • Start Date:

    2021-04-13

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of biologics to protect people worldwide from immunological diseases.

Role Description 
As a QC Stability & Release Associate you will coordinate the stability testing of large molecules products. 

Responsibilities 
- Coordinates the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.
- Coordinates the stability testing of large molecule products according local procedures and agreed timelines.
- Acting as subject matter expert on release and stability processes and has a leading role during the GMP inspections.
- Participates in meetings of the quality network organization and partners with customers to ensure flawless experience
- Responsible to coordinate all data requests provided by various stakeholders (RA; Health Authority; DPDS etc) and has the accountability to plan, organize, prioritize and execute the data requests based on the stakeholder requests.
- Leads and drives continuous improvement projects.
- Adhere to compliance best practices, EHSS regulations and lean principles.


Requirements 
- Bachelor’s degree (or equivalent) in a relevant discipline with 1-2 years of related working experience.
- Strong communication skills
- Advanced knowledge on lab systems and lab environment, data integrity and data management.
- Knowledge of statistical data analyses.
- Didactical skills to effectively transfer information in a training environment.
- Lean/BE experience
- Proactive stakeholder management


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 

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
The Netherlands
+31 (0) 20 658 9804