Date de publication Type de poste Lieu de travail Expérience Étude Disponibilité Langues Mobilité
31 mars 2023 CDI Tunis, Tunisie Entre 2 et 5 ans Bac + 5 2500 – 3500 DT / Mois Plein temps Français , Anglais
Description de l’annonce:
  • Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Defines strategies for writing documents,
  • Defines positioning for variation files,
  • Evaluates the conformity of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents.
  • Advises on pharmaceutical development: analysis of validation or stability reports.
  • Proposes to the client a strategy for validation, choice of specifications, stability plan.
  • Analyses and/or writes scientific reports based on raw data provided by the client
  • Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA file and factory procedures.
  • Carries out continuous regulatory monitoring/regulatory intelligence and communicates this to the teams
  • Contributes to the support and training of newcomers and colleagues (methodology, feedback,
    tools)
  • Applies internal processes and templates as well as best practices of the profession
  • Reports any deviation or problem to his/her manager and proposes corrective or preventive actions
  • Contributes to the drafting of processes / procedures and templates to serve the performance of consulting activities

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