C&Q Engineer QC Lab Specialist

Vor 5 Tagen


Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

This C&Q Engineer QC Lab Specialist will play a critical role in ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.) and supporting the setup, qualification, validation, and maintenance of laboratory environments.

This role involves working closely with our CSV Team and global IT teams to plan, coordinate, and execute commissioning and qualification activities for QC laboratory systems, equipment, and support utilities.

Key Responsibilities:
  1. Ensure compliance with relevant standards (GxP, FDA, EMA, ISO, etc.) as the C&Q SME for QC Laboratory scope.
  2. Plan and coordinate commissioning and qualification activities for QC laboratory systems, equipment, and support utilities.
  3. Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports.
  4. Maintain and report C&Q status to the C&Q Lead.
Requirements:
  • Bachelor's degree in Life Sciences or Engineering.
  • 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline.
  • Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
  • Strong knowledge of qualification and validation processes for laboratory systems and equipment.


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