Paraskevi Garyfallidi

Responsible for the management of the Quality System (ISO 9001). Handling of change controls, complaints, deviations, reviewing – updating SOPs, performing internal and external audits (for both finished dosage forms and semi-final, API manufacturers), reviewing and approving technical agreements. Performing release to the market of final products. Undergoing certification audits.

In charge of setting up a new QC dedicated for the analysis of sterile forms, preparing of the new set of SOPs, validations and relevant protocols for the equipment, raw and packaging materials and final products (release and stability studies for both chemical and microbiological testing). Training of personnel.

Quality overview of production, packaging and testing of products. Issuing of protocols and reports for stability studies, method validations, cleaning validations and process validations. Issuing of SOPs, review and update of old SOPs. Participating in GMP Inspections from National Authorities, from clients and in self inspections. GMP Compliance, FDA regulations

Final Release of products to the market, Quality overview of production, packaging and testing of products. Issuing of protocols and reports for method and cleaning validations. Issuing of SOPs, review and update of old SOPs. Managing of QC laboratory and personnel. Monitoring GMP Compliance of relevant fields Participating in GMP Inspections from National Authorities and from clients.

GMP Compliance, FDA regulations, GMP Inspections from National Authorities and from clients, Quality Assurance, Quality overview of production, packaging and testing of products.

Use of analytical equipment (UV/Vis, HPLC, GC, IR, INSTRONG, DISSOLUTION, OPTICAL ROTATION) for testing raw materials and final products. Performing: Method Validations, Process Validations, Cleaning Validations, Stability Studies Issuing SOP's, GMP Compliance / Training Specialty: Transdermals