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SAP QA/CSV Manager

  • Location

    Frankfurt am Main, Hessen

  • Sector:

    Demand IT & Business Engagement

  • Job type:

    Contract

  • Salary:

    €900 - €1000 per day

  • Contact:

    Clara Grace Moretti-Greene

  • Contact email:

    claram@montash.com

  • Salary high:

    1000

  • Salary low:

    900

  • Job ref:

    QACVS

  • Published:

    about 1 year ago

  • Duration:

    12 Months

  • Expiry date:

    2018-01-24

  • Startdate:

    ASAP

QA/CSV Manager

Rate: €900-€1000

Location: Frankfurt

Contract Length: 12 Months

Looking for a SAP QA/CSV Manager to work with a Global Manufacturing Organisation based in Frankfurt.

  • Support the regional "QA/CSV Manager" in order to ensure that processes within computerized systems (e.g. ERP (SAP), Trackwise)
    are implemented and used in a compliant manner (GxP) following internal and external regulations.
  • Approval of System Life Cycle documentation in compliance to the respective validation methodology.

Requirements

  • Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise (minimum of 5 years)
  • Must have strong experience of trackwise , SAP , ERP
  • Profound knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems -
    including external regulations e.g. EU-GMP Guideline, Data Integrity requirements and internal regulations
  • Risk Management capabilities (joint risk mapping, risk assessment, risk acceptance and risk communication)
  • Ability to prioritize and to effectively manage multiple tasks at the same time, quickly respond to changing internal and external requirements
  • Fluent in English (writing and verbal), preferable one additional regional key language.

Please note lots of travel is involved!!

Key Words:

SAP / ERP / CSV / QA / Quality / GMP / GxP / system life cycle / trackwise