Senior Scientist QA Operations
Key information
- Publication date:29 January 2025
- Workload:100%
- Contract type:Temporary
- Language:English (Fluent), French (Fluent), German (Fluent)
- Place of work:2500 Bienne
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
