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  • Job title:

    Quality Assurance Specialist

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  • Contact email:

    Carla Garcia

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    Carla Garcia

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The Company 

Our client is one of the largest pharmaceutical organizations world-wide, based in South-Holland. Their portfolio include various therapeutic areas such as oncology, respiratory, cardiovascular or infectious diseases. 

Role Description 

As a Quality Assurance Specialist you will be responsible for various activities such as CAPAs, deviation management, change control, batch release... to ensure that the products meet the quality standards. 

  • Identifies, classifies and reports deviations, as appropriate and typically works on more complex minor and/or major deviations.
  • Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone. 
  • Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
  • Responsible for providing quality oversight to the change management system for change controls. 
  • Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities. 
  • Participate in quality oversight of manufacturing, real-time observations of activities
  • Work closely with others to recognize opportunities for improvement and drive change through the use of QMS.
  • Participate in internal audits for compliance with SOPs, GMPs, and regulations.
  • Bachelor’s degree in biology, or chemistry, microbiology, or equivalent.
  • A minimum of 2 to 5 years of Quality Assurance experience in the pharmaceutical industry.
  • Demonstrated knowledge of cGMPs in a manufacturing environment.
  • Strong independent judgement and decision-making abilities.
  • Demonstrated problem detection and problem resolution skills.
  • Must possess good verbal and written skills.
Other Information 

For more information please contact Carla Garcia at +31 (0) 20 658 98 01 or