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  • Location

    Leiden

  • Job title:

    GMP Specialist

  • Sector:

  • Job ref:

    47012

  • Start Date:

    2021-11-11

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

Role Description 
As a GMP Specialist you will be the owner of GMP related processes such as audits and inspections, the deviation and change control process, evaluations and trend reports within Operations.

Responsibilities 
Keeping up-to-date and implementing improvements for the deviation and change control processes.
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Identifying and advising on deviations and change controls within the production process.
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Acts as SME and facilitates in complex and/or cross-departmental deviations.
- Organization of inspections within Operations and, together with QA Compliance, facilitates the staffing of the inspection teams.


Requirements 
BSc or MSc degree in Biotechnology, Biochemistry, Biopharma, (Micro)Biology, Process Technology (or equivalent training).
- Knowledge of cGMP requirements for both clinical and commercial manufacturing
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Experience within Quality Assurance is an advantage.
- Result - and performance-oriented, flexible, critical, problem-solving and innovative thinking.

- Good communication skills in English and Dutch.


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