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QC Consulant - Analytical Method

QC Consulant - Analytical Method

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact nameGuus Paulusse
Contact emailg.paulusse@panda-int.com
Job ref21895
Publishedabout 1 month 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