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Senior Scientist Qa Operations

Senior Scientist Qa Operations

Gi Life Sciences2500 Bienne, CH
22 days ago
Job description

For our Biotechnology partner, Gi Life Science is looking for a :

Senior Scientist QA Operations

Temporary position)

Your mission :

  • Review and release recombinant Drug Substance including review and release of purchased material, internally manufactured material and intermediates

Your responsibilities :

  • Implementation and Maintenance of Quality processes for Review and approval of master / executed batch records
  • Review and release of purchased materials, internally manufactured materials including buffer / media assemblies, intermediates and drug substance including writing of relevant procedures
  • Review and approval of operational elements such as procedures, related documents including specifications and associated quality records such as deviation, OOS, CAPA
  • Assist with continuous improvement initiatives related to quality documents and processes.
  • SAP Expert : QM Data setup, sampling plan setup and maintenance management, trainer
  • Performed site self-inspection
  • On call services (pickett light / 2nd level remote)

    Your profile :

  • BSc or MSc degree in Biology, Chemistry, Biotechnology or any relevant field
  • Min 3 to 5 years experience in pharmaceutical industry
  • Min 1 year experience in commercial batch release
  • Knowledge of pharmaceutical manufacturing processes (biologic drug substance a plus)
  • Experience in SAP and MES an asset
  • Eligible for nomination as a deputy RP
  • Language : English and French and / or German
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    Senior Scientist • 2500 Bienne, CH