Francesca Crippa Email & Phone Number

Milan, It

-Oversee GMP activities ensuring the cGMP compliance and enhancing continous improvement.-Ensure that the Quality Management System is fully applied in accordance with the cGMP.-Maintain and constantly improve the existing Quality Management System.-Ensure the oversight of external suppliers and subcontractors.-Ensure the application of the Risk Based Approach in order to identify risks and implement associated mitigation actions.-Coordinate, manage and execute internal and external audit.-Manage Regulatory Authorities Inspection and Client’s audit.-Ensure adequate personnel training program.-Support the Qualified Person for products release.-Manage and coordinate Quality Assurance team, strongly supporting teamwork and proactivity .-Manage communication with Clients.-Support Clients in regulatory documentation filing.

Milano

As Quality Assurance&Process Validation Supervisor my main activities were the following:-Define validation strategy for manufacturing processes by issuing the associated documentation (e.g. CPP Assessment, Risk Assessment, Validation protocols and reports etc).-Perform batch record review.-Manage change controls, deviations, including root cause investigation, CAPA and OOS.-Manage and coordinate Operations Departments involved in the process validation.-Support the revision of Client's regulatory documentation.-Support QA Manager during Client's audit or Regulatory Authorities Inspection.

Milano, Italia

-Support QA Manager to ensure cGMP compliance of production processes.-Manage changes, deviations, CAPA and OOS.-Exectute batch record record review, review Master Batch Record, Issue Product Specification File.-Support QA Manager during Client's audit or Regulatory Authorities Inspection.

Biologia Applicata Alla Ricerca Biomedica, Biology/Biological Sciences, General, 110 E Lode

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