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Pharma Project Manager: QA, Regulatory affairs, GxP

  • Location

    Germany

  • Sector:

    Project/Programme Delivery

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Leon Steffan

  • Contact email:

    Leons@montash.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    MON150121LS1_1610730638

  • Published:

    about 1 month ago

  • Duration:

    9 Months +

  • Expiry date:

    2021-01-22

  • Startdate:

    ASAP

  • Consultant:

    #

Project Manager PharmaRemoteArea: Gxp, QA und Regulatory affairs The service is requested for defined process regulatory tasks within life cycle management and maintenance projects.
Tasks: * Giving Technical advice to the project teams in project meetings with regard to regulatory requirements and official requirements and based on technical expertise. * Regulatory evaluation of change control requests in the change control system taking into account relevant SOPs * Commissioning the creation of quality documents by departments * Coordination of the creation of quality documents by departments. Tracking takes place in project meetings. * Review of quality documents - assessment of the content of the documents from a regulatory point of view, taking into account the requirements of the European and American animal health authorities and based on the expertise of the contractor * Creation of regulatory documents in accordance with relevant guidelines, in particular the variation guidelines and SOPs for carrying out change notifications * Compilation of submission packages / dossiers from the quality and regulatory documents using a compilation sheet (defined template) for handover to the publishing team * Review of submission packages / dossiers with regard to correctness and completeness according to compilation sheets after publication (before submission to European or American authorities) * Handover of the checked submission packages / dossiers for submission to the European Medicines Agency (EMA) on time * Timely responses to letters of deficiency or queries from authorities using predefined templates * Updating of records in internal approval and quality assurance databases for the named products to reflect the results of change notifications as well as communication and agreements with authorities



Skills:
  • Min. 3 - 4 years of experience in regulatory affairs (experience in RA CMC, variations in particular for centrally approved products, assessment of change controls, life cycle management / maintenance of products),
  • Microsoft Office programs
  • Databases, documentation experience
  • German Speaking is advantageous

Please me your CV's to: LeonS@Montash.de