Job Details

IT Quality Associate

  • €Competitive
  • Bietigheim, Germany
  • Permanent
Quality Associate – Computerized Systems Validation (CSV)

Location: Germany (remote)
Start Date: ASAP (permanent position)
Competitive Compensation Package + Benefits

Are you driven by innovation and the quest for scientific excellence? Our client, a leading Clinical Research Organization in Germany, is searching for a highly motivated Quality Associate to execute a variety of CSV tasks in line with GCP standards. With full training and certification provided, this role offers an ambitious individual the opportunity to develop into a CSV expert.

What will you be doing?
  • Manage computerized system validation projects for GxP relevant computerized systems.
  • Ensure computerized systems used in GxP operations are validated for their intended use (Computerized Systems Validation – CSV).
  • Support process and system owners in the following activities:
      • Collecting, describing, and analyzing business requirements for IT systems (business analysis).
      • Risk identification, risk assessment and risk mitigation.
      • Planning, conduct and report of CSV activities.
      • Performing periodic reviews of the validation status of systems.
  • Conduct manual or automated tests on systems, or support SMEs in the conduct of manual tests.
  • Improvement of internal systems for the planning, implementation, and documentation of CSV activities.
  • Ensuring inspection readiness of all GxP relevant computerized systems.
  • Support in the interface management with external partners and CROs, review of customer requirements and ensuring their fulfilment.

What do you bring to the table?
  • Pharmaceutical industry experience in Quality Assurance or Computer System Validation.
  • Good knowledge of good clinical practice (GCP).
  • Strong Microsoft Office proficiency. 
  • Excellent communication skills.
  • Fluent in English and German.
  • Graduate degree.

Robyn O'Toole Recruitment Consultant

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