Downstream Manufacturing Specialist

vor 18 Stunden


Bern, Bern, Schweiz Randstad Staffing Vollzeit
Job Responsibilities
The successful candidate will support routine GMP manufacturing process with focus on Downstream process steps (chromatography, Diafiltration/Ultrafiltration). Key responsibilities include:
  • SUPPORT ROUTINE GMP MANUFACTURING AND HELP IN TROUBLE SHOOTING AND PROCESS IMPROVEMENTS
  • DATA VERIFICATION
  • DATA TRENDING
  • WRITING OF SOP'S (FIRST DRAFT MBR'S, WORKINSTRUCTIONS, EQUIPMENT HANDLING) AND TRAIN OPERATORS ON THOSE DOCUMENTS
  • WRITING OF REPORTS (TECHTRANSFER/CAMPAIGN) AND TECHNICAL DOCUMENTS LIKE RISK ASSESSMENTS
  • SME (SUBJECT MATTER EXPERT) FOR QUALITY ISSUES, ROOT CAUSE ANALYSIS AND INVESTIGATION
  • INITIATING AND IMPLEMENTING OF CHANGE CONTROLS


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