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QC Consultant - Analytical Methods

QC Consultant - Analytical Methods

LocationVeenendaal, Netherlands
Business SectorPharmaceutical
Contact nameGuus Paulusse
Contact email
Job ref22190
Published23 days ago

I'm working exclusively with my Biopharma Client in the Netherlands, who is in urgent need for an interim QC Consultant to set up a a new project. Reason for the role being open is due to setting up a new team; so an initial 9 month interim contract is offered to a suitable candidate. If interested, send your CV to g.paulusse@panda-int.com ASAP, since interview + offer will take place this week.

Start Date: ASAP / Duration: 9 Months / Hours: 40 per week (2 days working from home is possible)


  • Support the Manager in the strategy of qualification & validation (Q&V) to have fit for purpose analytical methods (implementation of the total error approach)
  • Define design studies for qualification & validation
  • Write protocols, reports and compile the data
  • Make statistical analysis linked to Q&V
  • Interact with the analytical development department (PTD) to strengthen the analytical Quality by Design (aQbD) approach
  • Check GMP documentation (protocols, rapport) generated by the other Q&V project leaders (PL)
  • Support the QC laboratory in case of method troubleshooting
  • Interact with the customers/subcontractors
  • Manage deviations linked to the Q&V activities
  • Ability to discuss and challenge the strategy, results (included statistical analysis) and conclusions obtained during qualification/validation
  • Ensure that quality documents are properly delivered on time internally and to the customers
  • Understand customer needs and requirements to apply effective quality control method
  • Be on the lookout for opportunities for improvement and develop new efficient way of working


  • Ph.D, MS, Pharmacist, biochemistry and/or molecular biology with at least 5 years of experience
  • Strong knowledge and expertise in development, validation of analytical methods applied to protein and plasmid products
  • Strong knowledge of GMP rules/data integrity/trouble shooting
  • Experience within a CDMO is a plus
  • Languages: English & Dutch

Interview process: 1 stage interview process via Teams