Experience

Doppel Farmaceutici

• Italy
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Assurance site Manager

  • Oct 2020 - Present

  - Designing and improving quality systems (Change Control, Deviations, CAPAs, Product Quality Complaints) to realize the highest quality standards - Lead the internal audit execution, or actively participate in the audit execution as directed by the lead auditor and contribute to the successful outcome of all regulatory inspections - Negotiate and review all relevant Quality Agreements between Doppel and customers.- Provide Quality oversight on executed batch record review and batch release process - Maintaining Quality Metric data to support process improvement activities- Identifying and implementing continuous improvement opportunities for production activities- Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with cGMP, 21 CFR 211, ICH, other applicable regulations and current industry standards.- Review and approval of GMP documentation as Master Batch Records, qualification & validation protocols and reports, Validation Master Plan, Cross contamination Risk Assessments, Microbiological Environmental Reports and Water System Qualification and quarterly reports, stability protocols and reports Show less

• Regulatory Affair Specialist

  • May 2019 - Oct 2020



CTP SYSTEM

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Consultant

  • Aug 2017 - May 2019

  - Lifecycle maintenance: Pre-approval and Post-approval activities, Variation, Renewal, Response to Health Agency queries, Europe and International markets (US, Australia, Canada etc) - Implementation and Updating of Quality System Management (GMP, ISO 13485,ISO 9001) - Revision of Quality and Technical Agreements for outsourcing activities - Management of pharmacovigilance aspects - Supports the compilation, analysis and reporting of metrics, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements - Supports audit/inspection readiness of the organization and participates in regulatory and other quality and compliance report-outs. - Internal and external training activities Show less



Stevanato Group

• Italy
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Regulatory Consultant (Akka Technologies)

  • May 2018 - Dec 2018

  - Support in quality and regulatory issues for development of innovative Integrated Safety System syringes (ISS) in compliance with the all the current Medical Device Regulation - Writing and revision of raw development documents (protocols and reports) - Support in quality and regulatory issues for development of innovative Integrated Safety System syringes (ISS) in compliance with the all the current Medical Device Regulation - Writing and revision of raw development documents (protocols and reports)



Corden Pharma - A Full-Service CDMO

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Regulatory Consultant (AKKA Technologies)

  • Sep 2017 - Oct 2018

  - Writing of CDMO regulatory documentations as Module 3, Module 2, and responses to Deficiency Letters. - Writing of CDMO part of IND and IMPD for R&D product, including biotechnological product. - support in quality issues for definition of regulatory requirements of pharmaceutical products under development, in compliance with the all the current global quality guidelines - Writing of CDMO regulatory documentations as Module 3, Module 2, and responses to Deficiency Letters. - Writing of CDMO part of IND and IMPD for R&D product, including biotechnological product. - support in quality issues for definition of regulatory requirements of pharmaceutical products under development, in compliance with the all the current global quality guidelines



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Senior Regulatory Consultant (Akka technologies )

  • Aug 2017 - Jun 2018

  - Gap analysis of veterinary Drug Product dossier and its relevant follow-up - Regulatory strategy design and management of Dossier Variations - Technical and regulatory response to Health Authority queries - Gap analysis of veterinary Drug Product dossier and its relevant follow-up - Regulatory strategy design and management of Dossier Variations - Technical and regulatory response to Health Authority queries



Bracco

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affair & Quality System support

  • Sep 2014 - Jul 2017

  QUALITY ASSURANCE - Management of new products development process ; - Delivers project assignments supporting the business, e.g., representation on global cross-functional task forces or regulatory work streams - Defining and reviewing of Quality Agreement for outsourcing activities - Writing and updating SOPs - Management CAPA, change, Deviation and Complaints - Auditor assistant during suppliers' ISO and GMP audits - Support activities to ensure the Company's Compliance Inspections by the Health Authorities REGULATORY - Ensure adequate compliance management with all applicable laws and regulations and collaborate to perform alignment processes with achievement of better results - Define Regulatory documentations as Common Technical Document (Pharmaceuticals for human use), PIF (Cosmetic), Food Supplements Technical Document, Technical File (Medical Device) -Post-approval activities: - Variations, Transfer of Ownership Applications, Site transfer, PSURs, Renewals. - Updating of SmPC, PIL and labelling and revision of Artwork Show less



Università degli Studi "G. D'Annunzio" di Chieti

• Chieti, Italia

• University Research Scientist

  • Jan 2012 - Mar 2014

  AIMS Evaluate the potential antitumor effect of new anticancer co-drugs on malignant glioma in adults and children. AIMS Evaluate the potential antitumor effect of new anticancer co-drugs on malignant glioma in adults and children.



Private Pharmacy

• Pharmacy Internship

  • Mar 2013 - Dec 2013

  Main activities and responsibilities: - Developing and carrying out of all the activities related to managing a pharmacy; - Efficient use of phamacy related software; - Preparation of galenic formulations. Main activities and responsibilities: - Developing and carrying out of all the activities related to managing a pharmacy; - Efficient use of phamacy related software; - Preparation of galenic formulations.