Job Description
Major responsibilities
On shop floor quality oversight for cell therapy products to ensure product batch is manufactured according to approved procedure and in compliance with current GMP requirementsPerforms the QA review and approval of the following GMP documentation as it relates to the oversight scope to which the position is aligned:Validation and Qualification documentsDeviation InvestigationChange controlBatch Records and associated documentationProduct and material ReleaseOthers Quality Investigation (OOS, Complaints, Management ProceduresStandard Operating ProceduresLeads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systemsPerforms quality oversight of the utilities and facilities as per defined scheduleParticipate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory complianceParticipate in i...