I represent the Organization as Qualified Person vs. Italian MOH (AIFA) according to Italian DL.vo 219 and, according to that, perform the Final Batch Release (immissione in commercio) for all product manufactured (API).I manage all the activities related to Quality Assurance & Quality Control coordinating all the human resources of the Quality Group.I assure the full compliance with GMPs/GLPs EU & FDA rules.As certified Quality Assurance Lead Auditor, I can carry out Internal and… Show more I represent the Organization as Qualified Person vs. Italian MOH (AIFA) according to Italian DL.vo 219 and, according to that, perform the Final Batch Release (immissione in commercio) for all product manufactured (API).I manage all the activities related to Quality Assurance & Quality Control coordinating all the human resources of the Quality Group.I assure the full compliance with GMPs/GLPs EU & FDA rules.As certified Quality Assurance Lead Auditor, I can carry out Internal and external Audits.As RA manager I take care of all the Regulatory activities of the Organization, preparing DMF and maintaining updated all the existing Regulatory documentation Show less

- Responsible for EMEA region (Europe) of all the Sterility Assurance field for the Compounding division. The position reports to the Global Sterility Assurance Director.- Responsible for the Microbiological Quality of 2 Plants in Ireland (Dublin Deansgrange & Sandyford) and of 3 Plants located in France (Montpellier, Strasbourg, Lille). The responsibility includes also the direct interaction with the Local MoH (ANSM and HPRA) regarding all the Quality issues related… Show more - Responsible for EMEA region (Europe) of all the Sterility Assurance field for the Compounding division. The position reports to the Global Sterility Assurance Director.- Responsible for the Microbiological Quality of 2 Plants in Ireland (Dublin Deansgrange & Sandyford) and of 3 Plants located in France (Montpellier, Strasbourg, Lille). The responsibility includes also the direct interaction with the Local MoH (ANSM and HPRA) regarding all the Quality issues related to the 5 Plants, including Laboratory issues.- Responsible for the preparation of all Inspections- Support also (on demand), the 5 UK Plants regarding Quality of Finished Products.- Responsible for the Implementation of the EMEA MCMP (Microbial Control Master Plan) in all the 5 Plants with the aim to standardize and align all the Sterility Assurance Good Practices. Show less

- Represent the Site as Qualified Person vs. Italian MOH (AIFA) according to Italian DL.vo 219.- Perform the Final Batch Release (immissione in commercio) for all Baxter Sesto site production (Chemioterapics, MABs and Total Parenteral Nutrition) including the personalized therapies and Infusional Kits and Cardipolegia solutions- Manage all the activities related to Quality Assurance within Baxter, coordinating the Quality Assurance, Quality System, and Training &… Show more - Represent the Site as Qualified Person vs. Italian MOH (AIFA) according to Italian DL.vo 219.- Perform the Final Batch Release (immissione in commercio) for all Baxter Sesto site production (Chemioterapics, MABs and Total Parenteral Nutrition) including the personalized therapies and Infusional Kits and Cardipolegia solutions- Manage all the activities related to Quality Assurance within Baxter, coordinating the Quality Assurance, Quality System, and Training & Procedures group (17 HDs)- Assure the GMPs/GLPs Compliance according to EU rules - As certified Quality Assurance Lead Auditor, carry out Self Audits and External Audits to suppliers- Implement and approve the new technology choose by Baxter for the sterility testing (Flow Citometry of solid phase) Show less

Act as interface among the QA groups of all the ACS DOBFAR Italian Plants (8 plants) in order to accomplish and maintain the right level of GMP compliance and alignment among the Production Sites requested by EU & FDA GMPs.Participate to the selection of new Intermediates and Starting materials suppliers among the world.Responsible of the QA field for the building of a new fermentation & Downstream plant in Anagni for the production of a new sterile bulk antibiotic for USA, including… Show more Act as interface among the QA groups of all the ACS DOBFAR Italian Plants (8 plants) in order to accomplish and maintain the right level of GMP compliance and alignment among the Production Sites requested by EU & FDA GMPs.Participate to the selection of new Intermediates and Starting materials suppliers among the world.Responsible of the QA field for the building of a new fermentation & Downstream plant in Anagni for the production of a new sterile bulk antibiotic for USA, including the preparation of the FDA PAI Inspection. The inspection went very well with only 4 minor obs.Drive a project related to a finished dosage form third part plant (Brescia area) that has been chosen as production site for penicillin sterile finished products for US market arriving to the FDA approval. Show less

- Responsible of 3 Chemical Laboratories (Raw materials, Finished Products, Stability) and 1 Biological Laboratory and the Microbiological Environmental Monitoring group. In total 54 HDs.- Provide for the analytical support (Biological and Chemical) for all the AMEGA Area and their TPOs.- Carry out the Batch Disposition for all Cephalosporines API (BULK) manufactured by ACS-DOBFAR, and CHEMFERM based in Barcellona (responsible at global level, QA/QC).

Manage the QA group including the Registration group.Carry out internal and external auditsAssure the implementation of EU & FDA rules inside the plantAssure the implementation of all Corporate policies, procedures & Technical guidelines

- Responsibility for the building of a new QC Laboratory dedicated to the inspection and test of all the incoming materials.- Implement the NIRS technology for the identification of all the API.- Salvage and Returned Goods.

- Manage all the activities of a finished products Biological Laboratory including the Environmental Monitoring activities. 9 HDs in total