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GMP Compliance Engineer

vor 3 Monaten


Penzberg, Bayern, Deutschland Bertrandt Vollzeit
Job Overview:

We are seeking a dedicated Natural Scientist Engineer to join our team at Bertrandt. This role focuses on ensuring the quality and integrity of our Automation and Laboratory Information Systems (LIS).

Key Responsibilities:
  • Conduct quality assurance assessments for Automation and Laboratory Information Systems (LIS).
  • Oversee archiving processes, maintain master data, and ensure data integrity while adhering to quality assurance standards.
  • Develop and update Failure Mode and Effects Analysis (FMEA) within the Quality Risk framework.
  • Guarantee compliance with Good Manufacturing Practice (GMP) documentation requirements.
Qualifications:
  • A degree in a natural science field such as Biotechnology, Bioinformatics, or Computer Science, or a related discipline.
  • Knowledge of quality assurance principles and practices.
  • Familiarity with GMP, GAMP, and Computer System Validation (CSV) terminology.
  • Experience in Automation and Laboratory Information Systems is advantageous.
  • Proficient in both German and English.
  • Experience with SAP and ServiceNow is a plus.
What We Provide:
  • Engaging and challenging tasks.
  • Opportunity for independent work.
  • Extensive training and development.
  • Attractive compensation package.