Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Jan 2018 - Present

  -Evaluate and propose changes/improvement to guarantee an adequate sterility assurance level-Defining the Strategy for Aseptic Process Simulation design. -Issue of technical reports and risk assessments related to operator qualification and aseptic interventions for manufacturing of sterile lyophilized and liquids drug products (vials and pre-filled syringes) even under RABS.-Defining approach for EM trending data.-Define and maintain the Contamination Control Strategy of the site.-Responsible for guaranteeing that the production processes for sterile drug products are robust and respect sterility assurance requirements in accordance with current GMP.-Management of Non-Conformities (Deviation or Incident), Change Control and CAPA Processes.-Responsible of the Product Quality Review issues-Responsible of the issuing of MBR for Bulk and Sterile Production (plastic bags, vials, pre-filled syringes).-Quality oversight of filling line for vial and pre-filled syringes filling operations.-Perform contamination control walkthrough of clean rooms and utility systems.-Participate in internal and external audits as SME or Lead Auditor included Health Authority Inspections (e.g., AIFA/IT, Anvisa/BR, Cofepris/MX, FSI “SID&GP”/RU).-Assure compliance with Annex1 requirements.-Collaborate with the Engineering team to define the Commissioning activities (FAT, SAT) for new or modified equipments, utilities and computerized systems.-Responsible for the qualification of new or modified equipments, utilities and computerized systems.-Responsible of the equipment and utilities Requalification Program.-Responsible for all the activities related Process and Cleaning Validation, Continued Process Verification.-Manage and drive the suppliers in the qualification activities of the new or existing equipment.-Development of Site Validation Master Plan and Validation Project Plans to support major changes to the site. Show less

• • Oct 2012 - Dec 2018

  -Responsible of the issuing of MBR for Bulk and Sterile Production (plastic bags, vials, pre-filled syringes).-Responsible for Reviewing of Production BR for Bulk and Sterile Production (plastic bags, vials, pre-filled syringes).-Responsible of the “OCABR Procedure” at OMCL for “EU Official Control Authority Batch Release of Blood Product”.-Responsible for Product Release and Marketing documentation (EU and noEU Countries).-Collaborate and Support Pharmacovigilance department to handle Suspected Adverse Drug Reactions.-Responsible of Complaints, Recall and Return.-Management of Non-Conformities (Deviation or Incident), Change Control and CAPA Processes.-Responsible of the Product Quality Review issues.-Manage quality projects across functional areas and act as the quality representative for global projects.-Quality oversight of filling line for vial and pre-filled syringes filling operations.-Perform contamination control walkthrough of clean rooms and utility systems; provide recommendations and track actions.-Participate in internal and external audits as Subject Matter Expert (SME) or Lead Auditor.-Assure compliance with Annex1 requirements. Show less

• • Dec 2003 - Sep 2012

  -Collaborate with the Engineering team to define the Commissioning activities (FAT, SAT) for new or modified equipments, utilities and computerized systems.-Responsible for the qualification of new or modified equipments, utilities and computerized systems.-Responsible of the equipment and utilities Requalification Program.-Responsible of the critical instruments Calibration Program.-Responsible of the Environmental Monitoring - Total Particle - in all GMP Classified Area.-Responsible for all the activities related to Process Validation, Cleaning Validation and Continued Process Verification.-Manage and drive the suppliers in the qualification activities of the new or existing equipment.-Develop and improve validation procedures, practices, and policies-Set priorities, fulfill customer needs, define timelines, and track projects supporting the value stream. Ensure team deliverables are met within defined timelines.-Development of Validation Project Plans to support major changes to the site (e.g., new product introduction).-Development of Site Validation Master Plan. Show less

• • Jan 2003 - Dec 2003

  -Organization and coordination of the activities of the "Validations & Calibrations" Team.-Training of the "Validations & Calibrations" group.-Metrology (critical instrumentation calibration program).-Production of technical documentation of equipment and utilities (URS and FS).-Periodic calibration of critical measurement chains.-Periodic calibration of reference instrumentation for calibrations.-Review of Instruments Calibration Report.-Writing and Executing Validation Protocols.-Writing standard Operating Procedures for Calibration or Requalification.-Management of environmental monitoring of total particles classified areas. Show less

• • Dec 1999 - Dec 2002

  -Metrology.-Issue of technical documentation for equipment and utilities.-Calibration of critical measurement chains.-Writing and executing of validation protocols.-Writing Standard Operating Procedures.-Environmental monitoring in GMP classified areas (total particles).-Support to the external supplier Specialist for the validation of new production department.