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Helene DURRIS

BRUXELLES

En résumé

Specific skills in GMP manufacturing operations, vaccines production & aseptic processes.

Based on my experience, I have proven a fast adaptability in new environments and techniques, strong communication & influencing skills and good stress handling allowing me to manage strategic projects. I'm also able to run a portfolio management and alignment platform, act as portfolio manager for the projects contributing to the brand.
I'm used to to work effectively and sensitively in a matrix organization across geographies and cultures, multi-cultural awareness and interact with people from different areas of expertise (including more senior colleagues)

Specializations :
- Technology transfer
- V-Cycle
- Process Evaluation
- Process Validation
- Aseptic Environment
- Quality by Design
- Formulation/Filling/Visual Inspection of parenteral products
- Supply plan & performance management
- Issue & crisis management
- FMEA & Risk management
- Competitive intelligence

Mes compétences :
Environment
Manufacturing
Process
Technology
Technology transfer
Validation
Biotechnologie

Entreprises

  • GSK - Industrial Operations Product manager - Hepatitis & Travellers portfolio

    2016 - maintenant Direct the implementation of the manufacturing strategy and supply improvement initiatives for Hepatitis vaccines portfolio : management, planning, coordination and development of the strategic & tactical projects and programs aimed at improving and sustaining the supply reliability

  • GlaxoSmithKline - Senior Specialist - Manufacturing Center of Expertise

    Marly-le-Roi 2013 - 2016 Global Expert for Aseptic filling and visual inspection (automatic and manual) processes

    Key responsibilities include:
    - Support: Provide expertise support to Operations and Shared Services
    - Guidance: Define standards, methodologies (including best practices), tools and knowledge repositories.
    - Shared Learning: Training and certifications, skill assessments, coordination of a network of experts.
    - Governance: Assess state of progress towards vision

  • De Valck Consultants by Altran - Consultant Process Validation - GSK Bio

    2011 - 2013 Participate to the Process Validation (PV) and Process Robustness activities mainly on secondary manufacturing processes (i.e. immunostimulants, adsorption, formulation, filling and freeze-drying), for both under-development and commercialized vaccines

    - Analysis of the vaccines manufacturing processes and identification of critical and non-critical parameters of the manufacturing process modules
    - Establishment of evaluation plans and analysis of the results
    - Analysis of the Process Consistency of the manufacturing processes; support in the establishment of the Process Consistency protocols and reports
    - Establishment of the Process Validation documents
    - Support to Request for New File (RNF) and Request for Process Change (RPC) related to the process
    - Assure the coherence and harmonization between the Process Validation data created and submitted in the Regulatory files, as well as between the different projects

  • De Valck Consultants by Altran - Consultant Technology Transfer - GSK Bio

    2009 - 2011 Transfer of secondary operations (formulation, filling, freeze-drying, packaging) to CMOs or new GSK Bio site for diluent & pediatric vaccines in ampoules, vials & syringes
    Site donor coordinator

    - Coordinating all aspects of the filling transfer (engineering, process, supply, validation, logistic,QA, QC, regulatory affairs)
    - Establishing timelines for all steps and link with business timelines
    - Supporting technically the subcontractors (on site and from a distance) until validation batches
    - Writing documents related to transfer: Operationnal Transfer
    Plan,Product Transfer Specifications, Request for Process Change, Risk assessment and Gap analysis, Training plan,
    - Checking resources and equipment availability in receiving unit

    H1N1 pandemic crisis
    Site donor coordinator: transfer of adjuvant filling from GSK Bio site to 4 CMO’s (US and Europe)

    - Coordinating all aspects of the filling transfer (engineering, process, supply, validation, QA, QC)
    - Supporting technically the subcontractors (on site and from a distance)
    - Writing documents related to transfer (Process Transfer Specifications & Request for Process Change)
    - Leading meeting and teleconference internally with different departments and with CMOs

  • De Valck Consultants by Altran - Consultant Qualif/Valid at Baxter Healthcare

    2008 - 2009 Trainee/ Junior Consultant for Validation/Qualification

    - Drawing up of templates for Qualification and Validation tests.
    - Writing of URS/FS/DS for new manufacturing area
    - Qualification protocols and reports
    - Collaboration with engineering team for FATs

Formations

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