Alexandra J.

Document Manager at ADAM
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Contact Information
us****@****om
(386) 825-5501
Location
Meyrin, Geneva, Switzerland, CH
Languages
  • Français Native or bilingual proficiency
  • Anglais Full professional proficiency
  • Espagnol Limited working proficiency
  • Italien Elementary proficiency

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Credentials

  • ITIL Foundation V3
    PEOPLECERT

Experience

  • ADAM
    • United States
    • Design Services
    • Document Manager
      • Jun 2021 - Present

      Regulatory and Quality Department. • Documentation Service Responsible: generic mailbox administrator; numbering, convention naming, categorizing, standard formatting and uploading of documents from internal and external sources to QMS – Ensure compliance with all company’s policies and procedures – Assist in the Project’s documentation change, transmission and processes creation (PLM| CipherPoint|SharePoint Admin) Management of QMS documentation and product technical filing – Training, coaching and monitoring for documents control good practices (maintenance of KPI QA reports) – Business Analyst• Quality Assurance: Support Management Reviews and external Audits’ organisation and communication (ISO 13485:2016) – departments’ documentation reviews for compliance and audit readiness – Process Risk Management process support and training sessions’ lead. Change Management Process support.• Regulatory: Support the transition from MDD to MDR – Technical Documentation’s submission pathways’ process creation and data collection (IMDR N9) – Local Actor Administrator in EUDAMED – Assure compliance with regulatory agencies (FDA, MHRA, EUDAMED) (maintenance of KPI RA reports) Show less

    • Document Control Administrator
      • Sep 2020 - Jun 2021

      Quality Assurance Team Member

  • GSK
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Documentation Management & Engineering Compliance Support
      • Jan 2018 - Sep 2018

      Engineering & Facility Management Dpt – Infrastructure & Utilities Maintenance ServicePMO’s documentation’s migration project management [GxP|GMP].Technical Writer [SOP|Réf.|WI|GMP] : Drafting, proof-reading, copy-editing, formatting in MS. Cycle review, versions tracking and updating in Quality Management System [QA|QMS]. Translations [ISO Regulations]. Rationalization [Catalogs]. Standardization [Logbooks]. Archiving Coordinator – SharePoint Administrator : Regulated archive’s externalization process management. Filing system organization. Data consolidation. Index production. KPIs reporting [Pivot table|Graphic|Scorecard]: Energies. Documentation. Trainings. Coordination – Administrative Support – Logistics [Engineering Compliance Project Teams | Plant’s Executives]: Projects’ follow-up. Multi-components global reports’ update & submission. Complex meeting schedules & agendas set up. Minutes. Events' organization. Travels and visitors accommodation arrangement. Show less

    • Document Controller & KPI Project Coordinator
      • Mar 2016 - Dec 2017

      CAPEX Project : Plant’s extension & renovation with international prime contractor. Technical documentation’s flow management. Document and naming convention controls: PID – Plans – Datasheets – Contracts – Reports [IQ|OQ|PQ]. Filing system supervision. SharePoint Administrator: Users’ access rights management and support. Announcements. Libraries. Tasks lists. Calendars. Workflows’ development. Archiving.KPIs – Dashboards – Storyboards – Scorecards updates [Projects|Planning|Safety] 5S scoring.Communication : Presentations’ layouts [Steering Committee|Auditors|Townhalls]. Newsletters. Leaflets. Posters [PMO|Stands|Business Readiness|Safety|Supply Chain].Coordination – Administrative Support – Logistics [Executives|EH&S|Project Teams] Actions items monitoring. Reports, agendas. Meetings. Minutes. Onboarding. Official correspondance. Office’s supplies and equipment purchase [Procurement demands]. Coordination of financial processes [Invoicing|Expense reports]. Events’ and catering organization. Budgets follow-up. Show less

  • TEAM PARTNERS Suisse SA
    • Switzerland
    • IT Services and IT Consulting
    • IT Technical Support
      • Feb 2014 - Jul 2014

      Technical assistance to engineer a new Business Intelligence software (Pentaho) data model, in aim to calibrate tools and upgrade it with specific features for Real Estate Agencies’ assets management. Definition of dashboards, analysis reports and interactive scorecards. Operations, internet researches, application’s testing Technical assistance to engineer a new Business Intelligence software (Pentaho) data model, in aim to calibrate tools and upgrade it with specific features for Real Estate Agencies’ assets management. Definition of dashboards, analysis reports and interactive scorecards. Operations, internet researches, application’s testing

  • Givaudan
    • Switzerland
    • Chemical Manufacturing
    • 700 & Above Employee
    • Facilities Service Assistant Manager
      • Sep 2012 - Jan 2014

      Technical Teams Coordination Support to infrastructure projects [Changes|Tests|Move]. New processes development [Access Control|Change requests]. Contingency site’s suppliers’ & nearby actions management [Work Orders|Inventories|Checks]. Procurement.

    • Documentation Specialist
      • Jun 2008 - Jan 2014

      CMDB & new set of KMDB Governance. Service’s continuity monitoring and maintenance. Users support L1. Information collection. Documentation centralization. Information, data, records consolidation, update, storage, extraction & archive. KPIs reporting. CMDB|KMDB Developments Project Manager and Trainer [~100 co-workers/year]. Contact person [Auditors|Clients|Consultants].Technical Writer: Procedures. Users guides. Operational manuals. Assessment reports.

    • IT Technical Support
      • Jan 2007 - May 2008

      Global Users’ profiles management. Access rights granting. Operations on Operating Systems & applications. Workflow and ticketing. Issues’ tracking. Investigation. Screening. Problems solving. Escalation. Reports. International Service Desks & IT Managers L2|L3 support.

  • Top Desk
    • Advertising Services
    • Senior Administrative Assistant
      • Mar 2001 - Sep 2006

      Secretarial work - Receptionist : Correspondance. Newsletters' articles. Reports. Minutes. New companies administrative files support. Agendas management and meetings arrangements. Receptionnist. Organization : Business events, workshops, conferences . 2004 : Associate manager of Agro-Alimentary Caribbean Unit SARL : Project development, financial & administrative support Secretarial work - Receptionist : Correspondance. Newsletters' articles. Reports. Minutes. New companies administrative files support. Agendas management and meetings arrangements. Receptionnist. Organization : Business events, workshops, conferences . 2004 : Associate manager of Agro-Alimentary Caribbean Unit SARL : Project development, financial & administrative support

  • Sodexho Catering Services
    • United States
    • Food and Beverage Manufacturing
    • 1 - 100 Employee
    • General Housekeeper
      • Sep 2000 - Feb 2001

      Private Hospital Hotel & Catering Manager - EH&S Responsible (HACCP) - Staff Management (20) - Planning - Logistics - Procurement - Communication - New procedures & guidelines creation. Private Hospital Hotel & Catering Manager - EH&S Responsible (HACCP) - Staff Management (20) - Planning - Logistics - Procurement - Communication - New procedures & guidelines creation.

  • Marathon Petroleum Corporation
    • Oil and Gas
    • 700 & Above Employee
    • Administrative Office Manager
      • Dec 1996 - May 1997

      Staff Management (10) - Governance document management - US employees settlement operational and procurement duties - Purchase - Logistics. Staff Management (10) - Governance document management - US employees settlement operational and procurement duties - Purchase - Logistics.

  • Hôtel Le Printemps
    • France
    • Hospitality
    • 1 - 100 Employee
    • Hotel & Restaurant Manager
      • Aug 1996 - Nov 1996

      Staff management (10) - Training Officer - Coordination - Planning, Procurement - Purchase. EH&S (HACCP norms) Staff management (10) - Training Officer - Coordination - Planning, Procurement - Purchase. EH&S (HACCP norms)

  • Adecco
    • Switzerland
    • Staffing and Recruiting
    • 700 & Above Employee
    • Assistant Administrative Officer
      • Sep 1993 - May 1996

      Temporary missions : Secretarial work for Corporate Consultants, Private Banks, Architects, International and Local Industries. Editorialist Assistant : Type-writing. Advetorials drafting. Articles - Document - Ads Proof-reading - Private marketing events organization support for luxury brand Companies - Public Relation. Temporary missions : Secretarial work for Corporate Consultants, Private Banks, Architects, International and Local Industries. Editorialist Assistant : Type-writing. Advetorials drafting. Articles - Document - Ads Proof-reading - Private marketing events organization support for luxury brand Companies - Public Relation.

Education

  • Ecole hôtelière de Lausanne
    High School Diploma
    1992 - 1993

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