Tommaso Elia

Product Quality Manager - External Quality Assurance Sterile Platform @MSD

Latina, IT
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Nov 2018 — Present

Product Quality Manager - External Quality Assurance Sterile Platform @MSD

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Latina, IT

Home based in LatinaProduct Quality Manager - External Quality Assurance/Sterile PlatformMSDAreas of Responsibility- Product Release- Investigations of Deviations (Quality Events), Complaints, CAPAs assessment and monitoring until closure- Management of Change Control- External Party Inspection Readiness on Site support during audits- External Party Oversight (Relationship Mgmt, Metrics Mgmt, Quality Assessment)- Auditor - Third Party Manufacturers- Quality Agreement- Annual Product Review.

EDUCATION

1991 — 1997

Alma Mater Studiorum – Università di Bologna

Pharmaceutical Chemistry and Technologies

SKILLS

Fmea21 Cfr Part 11Project ManagementChange ControlBlendingHaccpTrackwiseSopAs400Quality AssuranceDicsonwareGmpPharmaceutical IndustrySapTechnology TransferConvalidaIndustria FarmaceuticaValidationTrasferimento TecnologicoControllo Della QualitàFdaConvalida Dei Metodi Di PuliziaIsoQuality AuditingControllo QualitàIbm IseriesSistema Di QualitàNorme Di Buona FabbricazioneQc-MainRegulatory AffairsConduzione TrainingQuality System

ABOUT TOMMASO ELIA

Following the path of study and subsequent professional experiences, I have acquired cultural and professional skills in the chemical and pharmaceutical areas. I gained twelve years of experience in the field of Quality Assurance in companies as Sanofi – Aventis and Bristol - Myers Squibb. Currently I hold the position of Onco Validation Project Officer at Corden Pharma Latina S.p.A. plant (Latina).

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Tommaso Elia — Product Quality Manager - External Quality Assurance Sterile Platform at MSD in Latina, IT | Unifers