Qualification and Validation Engineer (CSV+SAP+ISO+FDA+QSR+GxP+)

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6 months+
Von:
Larson Group
Ort:
Solothurn
Eingestellt:
14.06.2014
Land:
flag_no Schweiz
Projekt-ID:
726460

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Qualification and Validation Engineer

CSV + SAP + ISO + GAMP5 + FDA + QSR + GxP + Compliance

Exact title: CSV Lead for SAP

Location: Zuchwil

Duration: 6months +

Language Skills: English fluent, German is a plus

CSV Lead for SAP

Overall Responsibilities:

  • Working in a remediation project as a CSV Lead for SAP.

Tasks:

  • Cover the part of the GxP-Compliance in the project.
  • Creation of the Validation documentation for GxP relevant system elements.
  • Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations

Extended Duties:

  • Planning, coordination, execution and reporting of activities related to the project
  • Leadership for the QA Sub Project Team

Requirements:

  • Higher education (Engineer or similar) and background in IT
  • Responsibility in similar position or extended experience as executer required.
  • Knowledge of national and international regulations and standards
  • GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
  • SAP CSV Experience
  • Team Player
  • Excellent Communication skills