QA Specialist

Location Leiden
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 11906
Published: about 1 month ago

For my renowned Biotech client located in Leiden, I am urgently looking for a QA Specialist for the Quality Systems department. This is a 3 months project with a possible extension to 6 months.

 

Responsibilities

  • Collaborates in a matrix environment to drive handling of quality data (intrinsic quality)
  • For our internal audit program takes on the role of lead auditor or co-auditor depending on qualification and capabilities
  • Maintains the Site Master File
  • Assesses the site risks and maintains and improves the Site Risk Register
  • Supports and executes quality investigations (CAPA management) and change controls in a vaccine GMP environment
  • Represents the Quality department when needed

 

Profile

  • MSc in a scientific discipline e.g. Pharmacy or Bio-Pharmaceutical Sciences
  • 5+ years of quality assurance/quality control experience in a pharmaceutical GMP setting, by preference vaccines
  • Able to work and handle quality data /dashboarding (e.g Tableau knowledge would be an asset)
  • Knowledge of TrackWise system to manage quality issues and change controls
  • Knowledge of Risk management, RCA, CAPA management and Change Control Process
  • Experience with training delivery and curriculum management
  • Lead auditor or experienced with being a co-auditor in a GMP environment (by preference in vaccines)
  • Extensive experience with GMP-standards
  • Has experience with writing and maintaining a SMF and Risk Register
  • Language: English, knowledge of Dutch is an advantage

 

Interested?

If you’re interested in the above description, please upload your CV by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at  +31 (0)20 20 44 502 or by email at m.vanos@panda-int.com