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 requirements
Performs 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 Procedures
Leads and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
Performs quality oversight of the utilities and facilities as per defined schedule
Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance