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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)