14 days ago on careers.peopleclick.com

MES Business Analyst


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MES Business Analyst

MES Business Analyst
  • Requisition ID:144612
  • Position:Full-Time Temporary
  • Open date:12.10.2016 11:42
  • Functional area:IT
  • Location:Nyon
  • Required degrees:Bachelors
  • Relocation:Not Indicated
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    Basic qualifications:
    • Proficient in PasX version 2
    • Fluent in French
    • Previous experience of structured project management methodologies
    • Previous project management experience

    Preferred qualifications:
    • Technical bachelor (IT, analytical processes, chimical) or equivalent diploma
    • Minimum 3 years experience as MES administrator/Business analyst  if possible in  pharmaceutical or chemical industry domains  
    • Proficient in Manufacturing Information system (PasX version 3)
    • Familiar of GxP system validation/qualification
    • Previous pharmaceutical/medical sector work experience
    • Pro-active and independent on bringing the assigned tasks to a successful completion
    • Strong communication skills
    • Be experienced in the MS office tool like Excel, Powerpoint, Word
    • Fluent in English

    Job Purpose  

    During MES implementation project: business Analysis (sytem definition and implementation) for production manufacturing information systems in compliance with GxP regulatory rules and GSK internal rules

    After system go live: MES system administration and support in compliance with GxP regulatory rules and GSK internal rules

    Major Accountabilities  

    • Technical / Business Analysis for Manufacturing Execution System (MES):
    o Describe current MES applications (Process & Master data)
    o Analyse and describe Industrial IT production requirements using functional methods
    o Design future production processes and clearning processes and implement them into PasX information system
    o Ensure MES solution matches business expectations
    o Gather and prepare data to be uploaded into the new system/archived  (including Master Batch Records)
    o  Define and execute tests
    o Ensure first level technical support to users
    o Ensure MES operational administration (of which Patch and system releases deployment)
    o Ensure the good functioning of  system interfaces and take needed measure in case of errors
    o Establish data reports and data extractions as required
    o Be responsible for MES systems with the aim to enhance production equipements productivity

    • Training :
    o Prepare training materials
    o Train system end users (management, technicians, operators,…)

    • CSV
    o Participate in MES systems validation:
     Respect GSK processes (logic security, backup / restore & archive / retrieve processes, change and deviation  management, maintenance, recovery and continuity planning, CSV documentation management),
     Contribute in Validation strategy, risk assessment and test protocols (Installation Qualification, Operational Qualification and User Acceptance Tests) respecting international standards (GAMP5), GSK rules and reglementary requirements (21 CFR Part 11, EU GMP Annex 11),
    o Execute change requests on MES systems, inquire on deviations and follow up preventive and corrective actions

    • GMP
    o Audits follow up
    o Respect and make GMP standards be respected
    o Participate in MES related SOP redaction and maintenance
    o Proactively participate in maintaining validation/qualification statuses for MES applications

    • Communication :
    o Understand user requirements with the aim to provide adequate solutions
    o Communicate in a precise and timely manner requirements, results or problems between us-ers/validation responsibles/suppliers and propose constructive solutions
    o Be the single point of contact concerning MES systems

    Contact information:
    You may apply for this position online by selecting the Apply now button.

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