Catalent Pharma Solutions
- Project Manager Pharmaceutical Development
2007 - 2012
- Coordination & Management of the development activities for Soft Gelatin capsules (formulation, analytic, process) for projects at clinical stage (pre-clinical to phase III), for process technology transfer projects and process validation drove by the alignment of the strategic objectives.
- Responsible for process validation master plan definition based upon ICH Q8 (Quality by Design), for quality/compliance strategy definition, for regulatory support including CMC part review (IMPD/ANDA/NDA/MAA).
- Lead the communication internally with all departments involved, with the customers and all the affiliated sites (packaging, analytic, storage,…) maintaining high quality standards and strong technical skills.
- Ensure support to production for commercialized products (continuous process improvement, process investigations, root cause analysis, qualification of new references).
