CSV/IT QA Auditor

☞ Make A Healthy Change

Vue: 111

Jour de mise à jour: 25-04-2024

Localisation:

Catégorie: Ventes IT - Matériel / Réseaux Informatique

Industrie:

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le contenu du travail

JOB DESCRIPTION

Celerion is searching for a motivated


CSV/IT QA Auditor (100%)


to assure management that records, methods and practices are consistent with corporate policies, procedures and regulatory requirements. The emphasis of this position is relative to the validation of computerized systems and IT processes.

Responsibilities

  • Assure that Computer System Validation (CSV) activities and IT processes are in compliance with internal procedures, policies, and applicable guidelines and regulations
  • Represent QA on CSV/IT projects
  • Conduct CSV Audits, System/Process Audits and Vendor Audits when applicable
  • Advise System Owners, Validation Directors, System Users and IT on compliance requirements related to issues, projects and current systems
  • Evaluate proposed changes to computerized systems to determine validation or revalidation requirements and regulatory impact
  • Assist with Client Audits and Regulatory Inspections
  • Participate in process improvement projects and QMS activities (e.g. CAPA).

JOB REQUIREMENTS

Qualifications

  • Bachelor’s degree in Computer Science, Business, Science or related field
  • Knowledge of regulations related to Bioanalysis and Clinical Trials (e.g. GLP, GCP, FDA 21 CFR Part 11)
  • Computer System Validation and IT experience preferred
  • QA experience preferred
  • Excellent oral and written communication skills in German and English
  • Ability to organize and manage multiple priorities
  • Good time management skills

Our offer

  • Responsible role within a dynamic team
  • Competitive salary
  • Comprehensive training into your role and responsibilities

How to get into contact?We are looking forward to get your application (incl. motivation letter, CV, diploma, reference letters, etc.)

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Date limite: 09-06-2024

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