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