Simone Cassese

Advanced Consultant Process & Quality Unit at Aenova Group @Akkodis

Authoring, review and approve Risk analysis for cleaning activities. Authoring, review and approve cleaning validation protocols/procedures/test scripts for aseptic manufacturing. Authoring, review and approve cleaning validation scripts for API manufacturing. Authoring, review and approve Test run /Engineering run for cleaning activities on equipments in sterile area. Operational handling of change control and CAPAs related process/cleaning Validation Review and approve of Cleaning Validation raw data. Clean and Dirty Hold Time validations studies. Analysis and development of cleaning recipe for equipments in sterile area. Development of standard operating procedures (SOP) Authoring Risk assessment/technical documents for cleaning and process validation; Approach for validation activities; Authoring process validation protocol (PV) for sterile and no-sterile products, performance qualification protocol (PQ) and final report; Execution of process validation protocol; Process validation activities supervision; Collection of data from batch record; Interaction with others facility’s functions (Engineering, Quality Assurance, Quality Control,Tech.Transfer, Production) Authoring up of Holding Time Study for sterile products. Review the internal Validation SOP. Authoring of Packaging Validation documents related to cartoning machine and labelling machine.