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Principal 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

  • 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 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.


Other Responsibilities

  • Frequent inter-departmental, inter-organizational 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




Profil

  • In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment
  • Behavior competences: It is important that the person has an analytical and quality mind-set, is organized, communicative, flexible, eager to learn and enthusiastic.
  • Basic qualification: BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry.
  • Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers).
  • Experience in:
  • GMP
  • Analytical GMP methods of biologics/antibodies (release and stability of drug substance, drug products and diluent testing), both compendial and non-compendial methods.
  • Investigations, Deviations, change controls, CAPAs, method improvements and gap assessments.
  • Familiar with regulations (EMA/FDA/…)


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Formation et expérience

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