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Valérie LASSEIGNE

  • European Chemicals Agency
  • Regulatory Assistant

Helsinki, Finland

En résumé

Pas de description

Entreprises

  • European Chemicals Agency - Regulatory Assistant

    Administratif | Helsinki, Finland 2017 - maintenant DESCRIPTION OF TASKS

    * Processing of regulatory submissions according to REACH Regulation Article 20(2). The work is carried out as teamwork, according to working instructions, procedures and strict legal deadlines
    • Performing the technical completeness check (TCC) of registration dossiers. The work includes manual verification of data in the IUCLID dossiers. Decisions are documented and sent out via the REACH-IT
    • Rejections of registration dossiers due to incompleteness. Documentation of the decision-making process in Dynamic Case, drafting the decision in collaboration with the Legal Affairs Unit, sending out the decision via REACH-IT
    • Coordinate daily tasks related to the assessments of justifications of waiving the information required for registration
    -> organizing meeting with scientific, regulatory, legal experts; managers including the preparation of relevant documents
    -> participation in the development of the manual verification policy
    • Contributing to the drafting and review of instructions, such as internal ECHA user manual and instructions for processing of data waiving justifications

    * Company support
    I provide technical and regulatory advice to external customers requesting assistance with the submission-related IT tools, TCC failures or to the process of preparing and submitting a registration dossier
    • Replying to external enquiries and Helpdesk incidents via email or phone, and documenting in the Remedy customer relationship tool
    • Proactively contacting registrants via phone regarding complex completeness check failures
    • Making reminder calls to companies with an upcoming deadline under the TCC
    • Assisting in drafting Q&A related to TCC
    • Provide direct support to external customers during, events and training such as ECHAs stakeholders’ day, REACH 2018 Spring School and TCC webinar

    * Testing of submission-related IT-tools: REACH-IT and the IUCLID Validation Assistant tool

    * Internal training of newcomers and others unit members
  • European Chemicals Agency - Scientific Administratif Support

    Administratif | Helsinki, Finland 2016 - 2017 DESCRIPTION OF TASKS

    - Performing administrative activities related to REACH (REACH-IT and IUCLID 6) and Biocides processes (R4BP3 and IUCLID 6), for registration dossiers with respect to deadlines:

    • Performing manual validation of the Business Rules checks (for REACH and Biocides processes) to ensure that they meet administrative requirements
    • Processing Technical Completeness checks (for REACH) to ensure that no mandatory field entry is empty
    • Assessing the validity of the confidentiality requests from registrants about their data in the dossiers (for REACH) in Dynamic Case
    • drafting, editing, formatting and sending out decisions and communications via REACH-IT to the registrants for the outcome of: business rules, technical completeness check, confidentiality request
    • Keeping track of results and reports in Excel spreadsheets, Word documents

    - Managing, drafting and updating databases on a daily basis (e.g. Business rules quality checks) towards deadlines

    - Drafting, editing and formatting quality management documents and checking the implementation into the IT supporting systems (e.g. REACH-IT, Sharepoint).

    - Assisting in drafting technical documentation such as user manuals (e.g. REACH-IT user manuals, IUCLID user manuals, web pages) to help registrants in submitting dossiers that fulfill technical requirements

    - Handling telephone calls, e-mail enquiries, and correspondence with companies following Helpdesk Incidents related to registration

    - Contributing to the testing of REACH-IT 3.1: checking the correct implementation in the releases of the IT system according to the technical specifications

    - Organization of internal training of newcomers, including preparation of relevant training documents, in particular with respect to data submission.
  • ECHASA - Treasurer of ECHASA - Volunteer job

    Helsinki, Finland 2013 - 2016 DESCRIPTION OF TASKS

    - ECHASA Board member in charge of the Financial management:
    • general financial oversight: financial planning and budgeting
    • monthly financial reporting to the board
    • book keeping and record keeping
    • annual budget report submitted to the Agency in Word document and Excel spreadsheet in accordance with ECHA Regulations

    - Board member: organising Board meetings, preparing agenda and reports, involvement in decision making, activities and event planning.

    - Focal point for the international members as the Treasurer and as Board Member by providing administrative support to ECHASA members and their families for settling in Finland in English (international or multicultural environment)

    - Provide family support, when needed, by contacting by email or phone, developing communication (website) and organising meetings and events: monthly coffee morning, museum and factory visits, regular dinners, annual Family Christmas party, various trainings (sport, handicraft, cooking classes…) which include:
    • checking the costs
    • identifying suitable locations
    • liaising with representatives of organisations/institutions

    - Liaising with contractors for events organised by the Association, i.a. verbal and written communication, assessing quotations, ensuring that legal and financial commitments are in the place

    - Providing technical advice and assistance to the contractor for the implementation of a new website 2016/2017
  • FILAB - Technical Coordinator - Health & Nutrition - Chemistry Expertise

    Dijon (21000) 2010 - 2012 ACTIVITIES: Laboratory management, Customer relations, analysis of unknown products composition

    - Focal point as a technical Coordinator
    • for Staff: coordinating resource use (staff and equipment) in agreement with other Departments (multi-disciplinary teams) during weekly meetings to plan work within strict timelines
    Planning analyses, checking the performance of the analyses, ensuring compliance to working instructions and results reporting to customers within set deadlines

    • for national and international customers: defining needs to prepare quotations, sending relevant documentation, sending out reports with results with the Laboratory Information Management System (Tetraed). Providing company support via calls, e-mail and correspondence, organising face-to-face meetings, including preparation of support material

    - Following up of the analyses performed, documenting the results in the LIMS system, drafting, editing and formatting reports, sending out results to the customer after verification of the completeness of the report within set deadlines in French and English

    - Keeping track of emails, results, reports

    - Contributing to the procurement to perform analyses or to provide equipment: drafting documents for technical and scientific specifications, participating in procurement procedures and follow up of deliverables

    - Drafting quality management documents for the processes as SOPs and working instructions using MS Office, and keeping them up-to-date

    - Weekly quality check of different laboratory equipment (GC-MS, LC-MS, IRTF-)

    - Contributing to trouble-shooting and to the resolution of incidents on equipment; providing input to the root-cause analysis and to the corrective/preventative actions

    - Managing and updating the chemicals inventory and database documentation (monthly basis)

    - Training of laboratory technicians, including preparing training material and arranging training sessions
  • FILAB - Laboratory Technician

    Chenôve (21300) 2008 - 2010 ACTIVITIES: Analysis of of unknown products composition

    DESCRIPTION OF TASKS

    - Performing analysis of active ingredients, excipients, cosmetics, oils and fats, dietary supplements, fatty acids and sterols: determination of pollutant quantification (solvents, pesticides, VOC's, HAP, PCB), characterisation of nutritional status (protein, fat, carbohydrate, energy value).

    - Performing chemical analysis in the context of REACH to help companies to provide data to comply with their obligations

    - Handling samples from their arrival until the delivery of the results to the customer (LIMS): performing the analysis, documenting the results in the LIMS system, drafting, editing and formatting reports (MS Office) to be delivered to customers with respect to deadlines

    - Keeping track of emails, results, reports (using MS Office)

    - Supporting the certification of inter-laboratory comparison tests for fatty acid analysis (BIPEA - International Bureau for Analytical Studies)

    - Drafting quality management documents for the processes as standard operating procedures (SOPs) and working instructions (WINs) using MS Office

    - Perform weekly quality check on different laboratory equipment (GC-MS, LC-MS, IRTF…) to ensure performance of the equipment and the quality of the data

    - Contributing to trouble-shooting and the resolution of incidents on equipment; providing input to the root cause and performing the relevant maintenance

    - Supervision and training of temporary staff, including performing analyses in duplicate, preparing training material and arranging training sessions.

    Techniques used:
    • GC-FID (HS/GC-FID)
    • GC-MS (HS/GC-MS, ATD/GC-MS)
    •Spectrophotometer UV VISIBLE
  • Omega 21 - Laboratory Technician

    Dijon (21000) 2005 - 2008 ACTIVITIES: Project monitoring and analytical development

    DESCRIPTION OF TASKS

    - Performing chemical analyses according to instructions and within strict timelines to determine the lipid composition of:
    · dietary products for control and quality check
    · animal and human biological samples for Research & Development

    - Preparing analytical samples, data acquisition, processing, editing of analytical reports (MS Office) and verifying the completeness of reports before sending out decisions (SharePoint) within set deadlines

    - Focal point for customer service: managing telephone calls to send out documents/reports, e-mail enquiries and correspondence, organising face-to-face meetings, including preparation of relevant documents (Technical document), technical assistance if needed

    - Keeping tracks of emails, results and reports (using MS Office)

    - Quality, hygiene and safety: drafting of documents on technical and scientific matters such as standard operating procedures (SOPs) and working instructions (WINs)

    - Managing and updating the chemicals inventory and database documentation in Word document and Excel spreadsheet on a yearly basis

    - Performing weekly quality checks on different laboratory equipment (GC-FID, LC…) to ensure the performance of the equipment and the quality of the data. Contributing to trouble-shooting and performing relevant maintenance

    - Supervision and training of temporary staff, including performing analyses in duplicate.
  • Burgundy Sugar Mill Laboratory - Chemist

    Aiserey (21110) 2004 - 2004 Analysing:
    - Final product sugar (aspect, pigmentation, blur, grading, cleanness, filtrability, ash residue…)
    - Residual product pulp (moisture, percentages of ashes and silica)
  • Department of Clean Water Chemistry of the Institutional Laboratory of Côte-d’Or - Trainee

    Dijon (21000) 2004 - 2004 Analysis of drinking water (pH, blur, temperature, presence of ions and metals...)

Formations

  • Université Claude Bernard Lyon 1

    Lyon (69000) 2019 - 2020 Bachelor's degree - Analytical chemistry, quality control, environment: Analytical techniques
  • University Institute Of Technology Of Dijon - University Of Burgundy

    Dijon (21000) 2002 - 2004 DUT option Biological and Organic Food Industry

    Biological Engineering - Mention AB
  • Lycée Carnot (Dijon)

    Dijon 1997 - 2000 Bachelor of Science Specialization Physical Chemistry

    Mention AB

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