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QA/CSV Manager

  • Location

    Ingelheim am Rhein (55218), Rheinland-Pfalz

  • Sector:

    Information Technology

  • Job type:

    Contract

  • Salary:

    €700 - €850 per day + Negotiable

  • Contact:

    Amy Harris

  • Contact email:

    amyh@montash.com

  • Salary high:

    850

  • Salary low:

    700

  • Job ref:

    cvssap230117

  • Published:

    over 1 year ago

  • Duration:

    12 months

  • Expiry date:

    2017-01-22

  • Startdate:

    asap

  • Consultant:

    #

Montash have been engaged by a Global Pharmaceutical Client to source a Support Consultant to join the QA/CVS Manager on a global project

You will support the regional "Hub WA/CSV Manager" to ensure that the processes within computerised systems are implemented and used in a compliant manner following all external and internal regulations.

  • Approval of System Life Cycle documentation in compliance to the respective validation methodology
  • Support deployment according to the Quality Gate deliverables (e. g. Fit to Standard Workshops, training, etc.)
  • Ensure audit readiness and supports regional audits of systems in scope of the position
  • Regional interactions with all relevant business units (i.e. Production sites and commercial sites) and Global Functions, as well as cross functional project teams
  • Support the handover of quality tasks to the run organization
  • Support that further externals which supporting other internal department(s) are working under the agreed methodology.
  • Guides and defines work packages for external support and monitors the quality of deliverables.
  • Support the identification of local Key Users (e. g. for ERP (SAP), Trackwise) related to quality processes tasks
  • Partner with and educate business stakeholders and cross functional project teams through coaching and education regarding the need for compliance with regulations and quality management processes.
  • Manage existing/additional SOPs where applicable

Requirements:

  • Profound experience in a GxP regulated environment with focus on quality assurance and business process expertise (minimum of 5 years)
  • Profound knowledge on Computer System Validation, cGMP regulations and pharmaceutical QA systems -
    including external regulations e.g. EU-GMP Guideline, Annex 11, 21 CFR Part 11, Data Integrity requirements and internal regulations (LeVA)
  • Speak-up mentality/ ability to challenge and make judgment calls with Senior Management
  • Ability to manage externals and work in a matrix organization
  • 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
  • Respect and understanding of cultural diversities across the area of responsibility
  • Live BI's behavioral framework of Accountability-Agility-Intrapreneurship
  • Collaborative and integrated working style, act as solution contributor with proactive quality involvement
  • Fluent in English (writing and verbal), preferable one additional regional key language, e.g. Spanish for Central and South America, Mandarin for China/ Asia
  • Preparedness to travel

qa / cvs / sap / sdlc / system lifecycle / cGMP / GAM5 / uat test / sap ecc / annex