Giada Marcon Email & Phone Number

Latina, It

Roma, Lazio, Italia

Documentation management with related drafting, possible translation, modificationand evaluation; examining GAPs where present, taking corrective measures.Management of deviations within the production processes, with related investigationsand follow-up of the corrective actions deriving from the investigations carried out,using multiple sources of information and carrying out a historical analysis of the dataand evaluation of the Trends; using appropriate software (e.g. TrackWise)In detail, the activities carried out to date:Quality support for managing CAPA, deviations and non-conformities and forsupporting the release of batch records.Pre-validation phase (dry run) in which the effectiveness of the cleaning procedure istested.Validation of the cleaning procedure and DHT (Dirty Hold Time).Validation of storage conditions and CHT (Clean Hold Time).Preliminary Technical Evaluation of TT productsRegulatory analysis dossier of TT productsSupport for general review activities of the local quality management system throughthe alignment of existing SOPs to international and company requirements and, ifmissing, the issuing of new SOPs.

Latina, Lazio, Italia

Drafting of documents relating to process validation and/or cleaning (e.g. introductionof new products, modification of equipment, change of a product line, change of linewashing method, etc.)Technical supervision of field activities on manufacturing processes (mixing,granulation, compression, filming), packaging processes (blistering, bottles).Visual inspection activities on primary and secondary packaging.Ability to intervene, evaluate the resolution of any process anomalies, promptlyproviding indications and actions to be taken.

Via Costarica 20/22 Pomezia (Rm)

Drafting and editing of various documents such as: Master batch records, Protocols,Reports.Batch record reviewProduct cards, related to clinical pharmaceutical batches, in trial phase, validation.Document editing is also done due to changes related to the product (raw materials,packaging, parts of the process plant and requests from the customer or governmentagencies).Followed the compounding parts performed of the operators, the filling andpackaging part of the different pharmaceutical batches, and related samplingrequired by the type of product and customer.Collaboration together with Quality Assurance in the review and issuance ofcompany SOPs and analytical procedures.Followed up several projects, as a result of company requests, customer requests,or from regulatory agencies.

Via Morolense, 5 Ferentino (Fr)

Analyses on pharmaceuticals, sterile and lyophilized products under development,and intended for clinical use.The work was mainly focused on projects, which generally corresponded to theclient's product that contracts Patheon for various analytical and research activities,such as:Stability projects, compatibility projects.The different tests varied according to the type of project and the request from theclient.Listing a few, we perform: product reconstitution time, visual inspection of thereconstituted product, HIAC (particle counter), osmolarity, capillary electrophoresis,titers and impurities.

Latina, Lazio, Italia

Validation of methods following introduction of new production machinery and/orchange in process parameters, Transfer analysis.Analytical Batch Record reviewParticle size and chromatographic analysis (HPLC and UHPLC, UV, VIS, Empower3 Software), in particular: Mixture uniformity, physical assays (particle size, LOD,angle of repose and bulk density and relative density), on mixtures.Tests on tablets such as: Uniformity content, Assay and degraded products,peroxide determination, dissolution.Performing Cleaning Validation analysis, from product sampling on production lines,to sample analysis using validated methods.Routine analysis on plant water quality determination. The tests performedcorresponded to: Hardness, Chloride determination, Conductivity, pH, Total OrganicCarbon (TOC), Nitrate analysis, heavy metal analysis.Drafting laboratory events through the Trackwise system, investigating outliers,OOT/ OOS values obtained during the analysis.Conducting all necessary investigations in order to identify any possiblecorrective/preventive actions to be performed (CAPA)

Italia

Ottime capacità nel lavoro di gruppo, buona capacità di adeguarsi agli ambienti di lavoro conseguita dall’ esperienza in diversi ambiti. Ottima capacità nell’ integrarsi facilmente con altre persone.Ottima capacità organizzativa e di coordinamento nell’ambito delle mansioni lavorative.Utilizzo di apparecchiature analitiche quali: Spettrofotometro U.V/ VIS e I.R. , titolatori potenziometrici, karl fischer, rifrattometro, pH-metro. Buona conoscenza dell’utilizzo di tecniche cromatografiche, quali: H.P.L.C. , U.P.L.C. , G.C. e dei relativi software di utilizzo: TotalChrom, Empower3,

Bachelor'S Degree (Faculty Of Pharmacy And Medicine), Applied Pharmaceutical Sciences With A Curriculum In "Science And Technology Of Herbal Products"

Master (First Level), Management, Control And Maintenance Of Industrial Processes, Project Management, 110

Focus su, Processi industriali, Gestione della produzione, Automazione e Industrializzazione, project management, Metodi e Tecniche per la.

Education record

Activities and Societies: Specialization course regarding the coating process of oral solids, with particular attention to the coating.