Laurence Elkaim Email & Phone Number

Nice, Fr

Vallauris, Provence-Alpes-Côte D’Azur, France

Sophia-Antipolis

Key responsibilities:Team Management (2 peoples)IT infrastructure and lab informatics managementManaged computer equipment (200+ PC) - 50 % in LaboratoriesStudied and rolled-out document management system in Validated environment (GAMP5/21CFR11)Managing and reporting on allocation of IT budgetIdentifying and acting on opportunities to improve/update software/systems

Biot

Main activities- Project Management: from feasibility study to Assessment (and Cut Over) By using V or W Cycle or Agile (scrum) method By working closely with internal business users Establish budget (CAPEX & OPEX) with Finance department Contribute to draw up contract with Purchase Department Establish obviously planning, timelines and ressources needed - Contract management : Read & understood an IT contract: depends of types of contract in link with Purchasing & Outsourcing Department- Management of communication : Steering Committee, minutes meeting, project meetings with external or internal stakeholders- Design and implementation : Collaborate to the Installation of platforms needed (tes/Qualif/production) in relation with suppliers and/or internal IT- Accountable of Project deliverables : IT Approval Documents, RFP, Project Charter, URS, Architecture & Administration document, etc- Expertise in GxP Validation qualification documentation (V&V Plan, IQ, OQ, PQ, V&V reports, etc) according to GAMP 5 Strong regulatory environment applying 21CFR Part 11 guidelines Electronic records and electronic signature, GAMP standards Validation and Qualification project skills within Quality Assurance- Put in place all documentation for IT projects Team in NSH- Key systems implemented: Regulatory information system (RIMS), Laboratory Information Management System (LIMS), MES (Manufacturing Executive System), Scientific Documentation Management System (SDMS), Intranet portal (Sharepoint), Patent Management, Licensing Database Management, etc...

Sophia Antipolis

– Implementation of RIMS system for 300 users – worldwid tool – Cloud based Solution– Feasbility Study- URS ContributionUnderstand company needsUnderstand users needsUnderstand reulatory needs to be in compliance with EMA & FDA requirements- Tradcution in technology- Follow project processus :- Aware and responsible of project methodology– Follow planning , ressources & communication– Contract managemento With different suppliers– RFP management– Budget management and associated cost– Supplier evaluation then selection – Qualification/Validation according to Regulatory requirements and GxP requirements • Participate, elaborate to QA strategy and execution– Participate to technical Architecture• Technical Study of selectioned tools – Single Point of contact with external ressources

Sophia Antipolis

Defined project management methodology (from scoping to go-live) for R&D Project Team - Establish synopsis according to V cycle and/or Regulatory project or not - Create and harmonise IT documentation: Project Charter, URS, RFP etc... - Elaborate system classification to respond to the methodologyin collaboration with QA and all IT project leaders