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QC & Stability Associate

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Sophie Steels
Career Manager

Postulez ici

Sophie Steels
Career Manager

Sophie Steels
Career Manager

Description de l'emploi

Do you have experience with Validation or Technology Transfer? 

Then we are looking for you!

You will be responsible for:

  • for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
  •  Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
  • Contribute to the operation of Stability and Quality release testing programs across a multiproduct portfolio, managing timelines to meet corporate goals.
  • Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
  • Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
  • Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
  • Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA;
  • Contribute to stability and quality sections of Annual Product Review
  • Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
  • Complete sample submission forms; Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews
  • Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
  • Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
  • Contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site
  • Maintain department and project metrics, as appropriate.


  • Analytical background
  • Experience in Validation of Analytical methods
  • Experience with Technology Transfers is a plus
  •  4 - 5 years experience within QC (labo practical or method)
  • Statistical background is a plus to understand the proces
  • Knowledge ENG

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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
+32 16 309 509