Senior Scientist QA Operations

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