Qualification and Validation Engineer(CSV+Validation+German+GxP)

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6months+
Von:
Larson Group
Ort:
Solothurn
Eingestellt:
14.06.2014
Land:
flag_no Schweiz
Projekt-ID:
726595

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Qualification and Validation Engineer 80

CSV+Validation+German+GxP+GAMP5+ISO+Medical Devices

Location: Zuchwil

Title: CSV VALIDATION ENGINEER
Language Skills:  English fluent, German is a plus

Overall Responsibilities:

  • Project Quality Support in the CSV Remediation Project
  • Project Management & Leader Skills
  • Experience in SAP related validation activities.

Tasks:

  • Cover the part of the GxP-Compliance in the project.
  • Creation of the Validation documentation for GxP relevant system elements
  • Support in the creation of 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

Requirements:

Higher education (Engineer or similar) and background in IT

  • Experience 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 CFR, Part 820, Part 11
  • CSV Experience in the area of Medical Devices Manufacturing
  • Team Player
  • Excellent Communication skills

Non-Technical profile requirements: - Some flexibility in working hours is required - Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter; - Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines. Language proficiencies: -English spoken and written;