Longato Antonella

WORK HISTORY

EDUCATION

SKILLS

ABOUT LONGATO ANTONELLA

Pharmaceutical Processes know-how: High level of expertise in pharmaceutical manufacturing processes covering all dosage forms sterile and not sterile with technical background experience matured in worldwide companies at cGMP standard (FDA, EMEA). Knowledge of Single Use Manufacturing Technologies- Pharmaceutical Dosage Forms know-how : pharmaceuticals, veterinary medicinal products- Regulatory Affairs: Execution of programs to ensure compliance between manufacturing practices and product filings on a worldwide basis. Ensure changes with regulatory impact are properly processed and result in the necessary actions required to update regulatory filings and maintain regulatory compliance for markets worldwide. Resolve regulatory compliance issues for products manufactured in the plant. Ensure systems are in place and properly managed to ensure regulatory compliance for the local export markets. Liase with RA managers in order to insure adeguate support for routine registration activities. Provide Quality and Regulatory Compliance counsel to project development teams- Validation: Definition of Approach for PV studies, Validation of new and existing product manufacturing processes, Equipment/Utilities Qualification, leading technical and project management aspects- Quality Assurance: Experienced in QA for: Regulatory support to customers. Change management. Quality systems: Management of high complexity Investigations and Complaints, Trend analysis, Quality Key Performance Indicator (KPI), Product Quality Review (PQR), Risk Analysis; Audit : Active participation to Plant Regulatory Inspections (front room and back room coordination), external consultants, customers and Corporate Quality Assurance audits. • Soft skills: Leadership and planning skills. Ability to communicate, motivate and participate in effective multi-functional project teams. Good negotiation skills. Problem solving.