Qualification and Validation Expert

Vor 4 Tagen

Frankfurt am Main, Hessen, Deutschland ARCONDIS Vollzeit

Key Responsibilities

As a Qualification and Validation Consultant at ARCONDIS, you will be responsible for the qualification of equipment, instruments, and facilities. You will prepare qualification and validation plans for laboratory and production-related processes, as well as review specifications and risk analyses. Additionally, you will plan and witness SAT, FAT, and execute IQ-OQ-PQ. You will also process changes and deviations, create Standard Operating Procedures (SOPs), and maintain and archive documents.

Requirements

  • Successfully completed scientific or technical studies (e.g., Pharmacy, MedTech, Biotechnology, Engineering, Chemistry) or technical apprenticeship
  • Practical experience in a pharmaceutical laboratory, MedTech, or production environment
  • Very good GMP knowledge and in-depth knowledge of other regulatory requirements
  • Practical experience in quality assurance
  • Professional experience in qualification of laboratory equipment and facilities is an advantage
  • Experience in method validation of analytical methods is an advantage
  • Experience in LIMS or MES environment is an advantage
  • Careful, self-contained, and responsible way of working
  • Very good German and good English language skills as well as strong experience in working with computer systems
  • High degree of quality awareness, strong communication skills, and the ability to work in interdisciplinary teams
  • Willingness to travel

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