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Analytical Method Validation & Qualification Specialist

Analytical Method Validation & Qualification Specialist

LocationLiège, Belgium
Business SectorBiotechnology
Contact nameGuus Paulusse
Contact email
Job ref20630
Published8 months ago
I’m working exclusively with my Biopharma Client in Belgium, which is in urgent need for an interim Analytical Methods Qualification & Validation Specialist to set up a new team. Reason for the role being open is due to setting up a new team; so an initial 6 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: 6 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 & French

Interview process: 1 stage interview process via Teams