GMP Senior System Responsible performs activities related to Quality Assurance for the manufacture and release of API products. Support all QA activities for oversight of Manufacturing, Compliance, Auditing, and Release of product at external customers. Responsibilities include Review and Approval of Deviations initiated by Manufacturing or Quality Control, Investigations and CAPA, Review of Change Request, batch production records, method validations, and maintenance of compliance logs. Interact with internal cross functional groups including Technical Operations, Manufacturing, Quality Control, Regulatory Affairs, as well as Contract Manufacturing Organizations and Internal / External Stakeholders.In relation to Continued Process Verification, ensure the manufacturing processes: APIs and Intermediates are ready to be validated/qualified or remain in a validated state during their whole lifetime according to procedures, and in compliance with regulatory guidance.

Actually involved in the following activities dealing with New Projects:Approval of manufacturing and packaging master files; reviews batch records for manufacturing, packaging, testing, and deviations; ensures documents are in compliance; releases or rejects lots of raw materials, packaging components, imported bulk goods intended for production, and finished products intended for retail; issues appropriate certificates; assesses product returns.Management of the stability program: implements stability studies; establishes or confirms product expiry dates; drafts stability reports; recommends changes based on data analyses. Ensuring that customer complaints are handled: analyzes customer non-medical complaints; identifies trends and tendencies with respect to lot, product, and type of complaint and determines the cause; drafts complaint reports; recommends changes based on investigations and trend analyses. Management control of changes: helps evaluate change requests for equipment, primary and secondary components, processes, systems and various types of documents; monitors follow-up with parties involved; ensures that deliverables are compliant pursuant to the change; closes changes upon implementation.Involved in activities geared towards procedural improvements and document approval: reviews and approves product-quality failure and non-compliance investigations; performs follow-up on corrective and preventive actions pursuant to an incident; assists with process optimization; reviews standard operating procedures; assists with internal and external audits.Participating in the annual product review: reviews documents related to the products; compiles trend-analysis data and writes a trend-analysis report.

From 2011 to 2017, I have been a Post-Doc Senior Researcher at the Dept. of Pharmaceutical and Pharmacological Sciences, University of Padova. My main research interest lied in the organic synthesis in the field of Pharmaceutical Chemistry, and especially in the preparation and study of heterocycles and polyheterocyclic compounds mainly with potential antiproliferative, antimicrobial, anti-parasitic and/or enzyme inhibitory activity. During these last years, I became experienced with the most common synthetic processes and with all the physico-chemical characterization techniques, with a special regard to the NMR applications to complete structure elucidations.Professional Skills:Multidimensional (1D, 2D) and hetero-nuclear spectra acquisition, processing and analysis. Complete Structure Elucidation. Drug discovery by NMR. Peptide and Protein NMR Assignment (homonuclear and heteronuclear assignment). Peptide and Protein NMR structure determination.Liquid chromatography, thin layer liquid chromatography (TLC), high performance liquid chromatography (HPLC), Flash Chromatography.Biomolecules labelling, Radionuclide handling, Fluorescence and Fluorescence Polarized Spectroscopy, Circular Dichroism, UV spectroscopy.IR spectroscopy.Organic Chemistry Laboratory management, undergraduated student follow up, group meeting, synthesis and characterization of biologically active molecules.21 scientific articles in international peer-reviewed journals.

Served for nearby a decade as technical director of Iride 2000 srl company, dedicated to the promotion and sale of homeopathic medicines and herbals.

From 2006, I have been involved in the Radiopharmacy community and research, carrying on an activity covering different domains of the Nuclear Medicine, such as Cardiology and Nuclear Imaging, focusing my attention on the most widely used nuclear medicine radioisotopes, such as 99mTc, 188Re, 64Cu and 90Y. The above described research activity fully characterized my PhD and gave me the chance to became experienced with the synthesis and physico-chemical charaterization of different ligands (small molecules and peptides), with the synthesis of the corresponding complexes and with the subsequent in vitro and in vivo assays.

-Responsible for controlling, dispensing and distributing medicines and natural remedies to the public;-Keeping the register of controlled drugs for legal and stock control purposes;-Managing, supervising and training pharmacy support staff;-Liaising with doctors about prescriptions;-Advising on over-the-counter medicines and vitamins and mineral supplements;-Advising patients of any adverse side-effects or potential interactions with othermedicines/treatments;-Monitoring blood pressure and cholesterol (HDL, LDL) and triglyceride levels;-Offering a diabetes screening service and monitoring the glucose level.