Product Expert

Major Accountabilities:

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
• Create and maintain a product specific Quality Risk Analysis (QRAs).
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Ensure inspection readiness for all process related aspects of assigned products.
• Track and evaluate product performance, trending, detect issues, implementation of CAPAs
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
• Design and manage optimization projects.

Essential requirements:

• Degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree.                       
• 6-8 years of experience in Process Support/Process Expert roles within the MS&T department of a pharmaceutical company.
• Extensive knowledge of GMP and analytical methods validation.
• Experience of data handling and applied statistics.
• Fluent in English and Italian.