Principal Qc Stability Associate

il y a 1 semaine

Geel, Flandre, Belgique Pauwels Consulting Temps plein

Responsible 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.
  • Coordinate and manage qualified materials program. Coordinate/Lead multiple site/global projects and represent QC across organizations.
  • Contribute to the operation of Stability and Quality release testing programs across a multi[1]product portfolio, managing timelines to meet corporate goals.
  • Execute reagent requests from testing labs (including incountry 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.
  • Support Sanofi oversight of procedure and document changes at CLOs.
  • Participate in routine internal and external Operations Meetings
Other Responsibilities

  • Frequent interdepartmental, interorganizational and external interactions
  • Reviews and compiles data for CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed
  • Support the development and management of quality agreements between Sanofi and internal/external parties
  • Financial management and planning of analytical purchase orders for CLO testing activities and reagents, as well as any other planned analytical activities under responsibility

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