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  • Location

    Leiden, Netherlands

  • Job title:

    QA Validation Specialist

  • Sector:

  • Job ref:

    44842

  • Startdate:

    2020-09-02

The Company 
This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines.

Role Description 
As a QA Validation Specialist you will lead projects related to construction, utility and equipment introduction / software.

Responsibilities 
  • Serves as a dedicated quality representative on project teams responsible for design and development of drug products.
  • Serves as the primary quality assurance contact for internal and external business partners and contractors.
  • Provides tactical insights into regulatory compliance strategies.
  • Focuses on technical issues relative to interpretation of policies, compliance and current industry standard.
Requirements 
  • Bachelor's degree in Chemistry, Biochemistry, Engineering, Pharmacy, Biotechnology or similar. 
  • At least 10 years relevant work experience in QA and validation.
  • Up to date GMP, FDA, IGJ knowledge and experience
  • Validation, qualification and automation experience in construction, equipment and software.

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

 

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