Thermo Fisher Scientific: Qc Data Integrity - Lombardia, Italia - Confidenziale

Confidenziale

Azienda verificata

Lombardia, Italia

4 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

As QC DI specialist, you will join the QC LIMS & Data Integrity team.

Your duties and responsibilities will mainly involve:

Operate as Empower 3 SME:
Empower is an electronic system for the control of chromatoraphic instruments and data:
Be point primary of contact for Global Administration and support systemBe point primary of contact for site users troubleshooting and supportOwn the mangement of related documentation (procedures, work instructions, reports)Act as SME for Empower custom fields development and validationOperate as Data Integrity specialist, during the installation and update of all the software controlling the analytical equipments of the QC lab:
Define possibble issues and preventive actions related to electronic data management, prior to validation activitiesdefine, together with the stakholders, the permissions to be assigned to users and the best workflow to operate on the software, in order to ensure both GXP Compliance and businesstimeline adeherencedefine the relevant instructions related for audit trail and electronic data reviewOperate as Data Integrity specialist:
Evaluate and investigate, together with Compliance dept, potential DI anomalies occurred during GMP review of audit trails and electronic dataParticipate to audits from clients and regulatory agenciesParticipate to the deployment of new Global LIMS SM systemCollaborate with other functions invoved, as required:
QC labs, QC Compliance, QA, IT, CSV, CorporateRequired technical skills:

Good knowledge of Empower 3 CDS system, including also custom fields functionalityAdvanced knowledge of GMP and Data IntegrityAt least 3 years of experience in QC Labs and familiarity with analytical techniques and equipments, such as HPLC, GC, spectrophotometry,...

Basic knowledge of IT and CSV (Computerized Systems Validation) is a plusAutonomous English knowledge, both written and spokenRequired soft skills:

Extreme precisionAttitude to think ahead, anticipate problems and propose solutionsAttitude to teamwork and self-organizationInterpersonal skill