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Work Background
Head of QC
Mozarc MedicalHead of QC
Apr. 2023Tovo S. Agata• • Head of Microbiological and Chemical Quality Control Laboratories • Laboratory STAFF MANAGEMENT (5 supervisors – 17 analysts) • Drafting of the annual department BUDGET • Coordination of expansion and optimization PROJECT of the QC department • Management of department TIER and participation in company TIER • Participation to ANNUAL MANAGEMENT REVIEW • Supervision of LABORATORY ACTIVITIES • Review and approval of all SOPs and LABORATORY DOCUMENTATION, risk assessments, validation Protocols and reports. • Supervision of chemical and microbiological METHODS VALIDATION • MANAGEMENT OF SUPPLIERS for the procurement of materials • MAINTENANCE, CALIBRATIONS, QUALIFICATIONS AND INSTRUMENTAL REQUALIFICATION • Laboratory OOL, OOS, NC management • Collaboration and support CROSS-FUNCTIONAL TEAM for projects, NC, CAPA, changes with decisions/actions relating to one's area of expertise, whether linked to the production routine or to new projects. • Participation in INSPECTIONS (INTERNAL AND EXTERNAL AUDIT) of regulatory bodies/Corporate/customers and managing any corrective actions within their competence
Head of QC
MedtronicHead of QC
Dec. 2022 - Apr. 2023Tovo di S. Agata• • Head of Microbiological and Chemical Quality Control Laboratories • Laboratory STAFF MANAGEMENT (5 supervisors – 17 analysts) • Drafting of the annual department BUDGET • Coordination of expansion and optimization PROJECT of the QC department • Management of department TIER and participation in company TIER • Participation to ANNUAL MANAGEMENT REVIEW • Supervision of LABORATORY ACTIVITIES • Review and approval of all SOPs and LABORATORY DOCUMENTATION, risk assessments, validation Protocols and reports. • Supervision of chemical and microbiological METHODS VALIDATION • MANAGEMENT OF SUPPLIERS for the procurement of materials • MAINTENANCE, CALIBRATIONS, QUALIFICATIONS AND INSTRUMENTAL REQUALIFICATION • Laboratory OOL, OOS, NC management • Collaboration and support CROSS-FUNCTIONAL TEAM for projects, NC, CAPA, changes with decisions/actions relating to one's area of expertise, whether linked to the production routine or to new projects. • Participation in INSPECTIONS (INTERNAL AND EXTERNAL AUDIT) of regulatory bodies/Corporate/customers and managing any corrective actions within their competence
Microbiological laboratory Supervisor
MedtronicMicrobiological laboratory Supervisor
Apr. 2022 - Dec. 2022• Coordination of expansion and optimization PROJECT of the QC department • Management of department TIER and participation in company TIER • Supervision of LABORATORY ACTIVITIES • Review and approval of all SOPs and LABORATORY DOCUMENTATION, risk assessments, validation Protocols and reports. • Supervision of chemical and microbiological METHODS VALIDATION • MANAGEMENT OF SUPPLIERS for the procurement of materials • MAINTENANCE, CALIBRATIONS, QUALIFICATIONS AND INSTRUMENTAL REQUALIFICATION • Laboratory OOL, OOS, NC management • Collaboration and support CROSS-FUNCTIONAL TEAM for projects, NC, CAPA, changes with decisions/actions relating to one's area of expertise, whether linked to the production routine or to new projects. • Participation in INSPECTIONS (INTERNAL AND EXTERNAL AUDIT) of regulatory bodies/Corporate/customers and managing any corrective actions within their competence
Associate quality system
MedtronicAssociate quality system
Nov. 2021 - Mar. 2022Tovo S Agata• Change control process management • Quality procedures update • QA Batch review • CAPA management related to external audits • Participation in daily TIER IV production as a Quality representative. • Initial training for new hires: Knowledge of good manufacturing practices and ISO 13485 - Quality policy and its objectives
Q&C Specialist (Quality and compliance)
Baxter International Inc.Q&C Specialist (Quality and compliance)
Jul. 2018 - Nov. 2021Valtellina- Perform and management of internal audits - Management of external audits by regulatory bodies, notified bodies (FDA, AIFA, TUV, BSI), customers; -coordination of non-conformities and related CAPAs detected during them - Training of staff on company management procedures • Coordination of interdisciplinary compliance projects, with a view to continuous improvement • Management of problem solving projects (Green belt) and corporate VIPs with a view to optimizing processes • Management of relationships with third party customers (quality part): opening of internal changes for the implementation of new products or implementation of changes to existing products, drafting of Quality agreements. • Management of batch documentation and related updating • Management of internal audit process and related actions; • Management of the external audit process and related actions through the Baxter TrackWise 7 IT system; • Management of GQP implementation process and related sharepoint update; • Global Certification Program process management and related sharepoint update; • Task owner in the Baxter TrackWise 8 IT system: impact analysis and management of tasks related to updating the Master Batch record. • Master Batch update through the AS400 system (MILD). • Preparation of monthly CAPA Board slides and quarterly MANAGEMENT REVIEW regarding internal and external audits and global certification program. • Participation in the daily TIER II production as a Quality representative. • Initial training for new hires: Knowledge of good manufacturing practices and ISO 13485 - Quality policy and its objectives - adverse events and complaints training - iCare program training.
Quality Assurance Quality Control
D.B.M. S.r.l. - AZIENDA MEDICALE DI DISPOSITIVI MEDICIQuality Assurance Quality Control
Nov. 2015 - Jul. 2018Sondrio, ItaliaQuality assurance and control; Research and development. Management of quality system documentation and batch documentation (Master Batch Record and Revisine Batch finished product record); Complaints and CAPA management; Qualify suppliers; Management of Quality Agreements with main customers and suppliers; Management of internal audits and external audits (customers / certification bodies); Management of product validations and calibration of equipment and instruments; Management of the production department, staff training;
Post graduate - Registar in clinical biochemistry
Ospedale San RaffaelePost graduate - Registar in clinical biochemistry
Jul. 2012 - Jul. 2017Segrate, Lombardia, ItaliaLarge automation activities, hematology and coagulation, clinical separative biochemistry and clinical proteinology, clinical microscopy and cytology, immunochemistry, clinical pharmacology and toxicology, cellular biochemistry and cell cultures, clinical hormology Outpatient activity at the blood sampling center
Research Fellow AIRC (CO Co Pro)
Gruppo San DonatoResearch Fellow AIRC (CO Co Pro)
Dec. 2010 - Oct. 2015San Donato Milanese, Lombardia, ItaliaInvolvement of sialidases in the carcinogenic process. Study of Neu3 sialidase in human melanoma (AIRC-funded project) and in renal carcinoma. Study of sialidase Neu4 in glioblastoma cells and in the neurospheres derived from them. work in sterile conditions (pi and pii hoods) - cellular and bacterial cultures - cellular assays: adhesion test, migration test, proliferation test, invasiveness test, zymography - enzymatic activity assays: sialidase activity - extraction and quantification of proteins - electrophoresis of nucleic acids and proteins - westen blot - immunoprecipitation - elisa test - metabolic labeling using tritiated sphingosine and tritiated thymidine - extraction and partitioning of lipids, separation by tlc and quantification by b counter - pcr e - gene transfection - rna interference through lentiviral vectors - extraction and quantification of DNA and RNA from blood, cells and salivary swab - realtime PCR (syber green and taqman technology)

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