QA/CSV Manager

Vertragsart:
Vor Ort
Start:
keine Angabe
Dauer:
12 months
Von:
Montash
Ort:
Rheinland-Pfalz
Eingestellt:
24.01.2017
Land:
flag_no Deutschland
Projekt-ID:
1274026

Warning
Dieses Projekt ist archiviert und leider nicht (mehr) aktiv.
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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 (ie 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 eg 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, eg Spanish for Central and South America, Mandarin for China/Asia
  • Preparedness to travel

qa/cvs/sap/sdlc/system life cycle/cGMP/GAM5/UAT test/sap ecc/annex