Koch
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Qualified Person

Description

The Qualified Person (QP) is responsible for confirming that the manufacturing fulfills procedures, customer agreements and regulatory guidelines ahead of product release. In this role, you will also have the opportunity to support Quality Department while helping our production and project development team. 

What You Will Do In Your Role

  • Take active part into expanding the existing QMS to allow drug handling. 
  • Ensure approval by Health Authorities to handle drugs.
  • Confirm partial manufacturing (batch release). 
  • Ensure documentation is kept up to date as operations are carried out. 
  • Assemble necessary documentation to be shared with the Customer to allow final batch release.

The Experience You Will Bring

Requirements:

  • University degree (at least 4 years) in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry or biology.
  • Experience working as a Qualified Person. 
  • Practical experience with up-to-date Good Manufacturing Practices (cGMP).
  • Good knowledge of current Good Distribution Practices (GDP).
  • Basic knowledge of pharmaceutical development and clinical trial process.
  • Ability to perform well on individual tasks. 
  • Ability to integrate into a multi-cultural and multi-disciplinary team.
  • Fluency in English (verbal and written communication).
  • Good computer skills, especially for Microsoft Office.
  • Knowledge in process and equipment validation requirements and processes.

    What Will Put You Ahead

    • Previous working experience in production, qualitative analysis or quality control for a pharmaceutical company holding a Manufacturing & Importation Authorization (MIA).
    • Project management experience.

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