Détails de l'annonce
Référence
177274
Date de publication
30 avril 2023
Type de contrat
Lieu de travail
Tunis, Tunisie
Expérience requise
Entre 2 et 5 ans
Niveau d'études
Bac + 5
Salaire proposé
2500 - 3500 TND / Mois
Disponibilité
Plein temps
Langues
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Entreprise
PRODUCTLIFE GROUP
Secteur: recrutement / ressources humaines
Taille: Entre 200 et 500 employés
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
