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Synthetic Molecules Development Expert

vor 1 Woche


Basel, Basel-Stadt, Schweiz Roche Vollzeit
About the Role

We are seeking a highly skilled Calibration Coordinator to join our team at Roche.

This role is critical for the smooth operation and compliance in the manufacturing and development of synthetic molecules, providing our partners with high-quality services according to cGMP guidelines.

The successful candidate will be responsible for conducting calibrations on manufacturing equipment and analytical devices for Drug Substance (DS) and Drug Product (DP), including GMP-compliant documentation.

In addition, they will coordinate calibration activities in consultation with internal partners, organize external service providers, create/edit deviations including root cause analysis, and create/edit Corrective & Preventive Actions (CAPA).

Your Responsibilities:

  • Conduct calibrations on manufacturing equipment and analytical devices for DS and DP
  • Coordinate calibration activities with internal partners
  • Organize external service providers
  • Create/edit deviations including root cause analysis
  • Create/edit CAPA
  • Create/edit changes
  • Create/edit calibration specifications
  • Manage measuring instruments
  • Maintain calibration master data
  • Expand the calibration springer function in DS and DP
  • Participate in commissioning and qualification of new equipment
  • Provide expertise during regulatory inspections

Your Profile:

  • Completed vocational training in a technical or pharmaceutical field
  • At least five years of experience in a GMP environment
  • Strong technical background and solid understanding of chemical/pharmaceutical plants and their automation
  • Experience working according to cGMP guidelines
  • Ideal experience in calibrating measuring devices for chemical/pharmaceutical manufacturing plants
  • Good knowledge of English and German, both written and spoken
  • Positive, independent, proactive, and integrative personality
  • Open to the digital world and willing to expand skills in digital systems
  • Results-oriented work style, sense of responsibility, and interest in continuous process improvement
  • Self-motivated, curious, and committed to continuous learning
  • Inclusive mindset, teamwork, and enjoyment in working with people