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 recordsReview and release of purchased materials, internally manufactured materials including buffer / media assemblies, intermediates and drug substance including writing of relevant proceduresReview and approval of operational elements such as procedures, related documents including specifications and associated quality records such as deviation, OOS, CAPAAssist with continuous improvement initiatives related to quality documents and processes.SAP Expert : QM Data setup, sampling plan setup and maintenance management, trainerPerformed site self-inspectionOn call services (pickett light / 2nd level remote)
Your profile :
BSc or MSc degree in Biology, Chemistry, Biotechnology or any relevant fieldMin 3 to 5 years experience in pharmaceutical industryMin 1 year experience in commercial batch releaseKnowledge of pharmaceutical manufacturing processes (biologic drug substance a plus)Experience in SAP and MES an assetEligible for nomination as a deputy RPLanguage : English and French and / or Germanjidd8a72a1a jit0207a