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QC & Stability Associate

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Sophie Steels
Recruiter



Sophie Steels
Recruiter


Job description

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.


Profile

  • 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


Apply now for QC & Stability Associate

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