Review and approve GMP docs (facility plans, validation, CSV, CAPAs)
Author and maintain the IDMO Site Validation Plan
Provide QA oversight of process validation and PPQ
Oversee cleanroom lifecycle: aseptic simulations, EM PPQ, cert/recert
Identify and resolve technical and regulatory issues/gaps
Support multiple areas/facilities needing regulatory and QA knowledge
Ensure adherence to procedures/regulatory expectations for facility/equipment release
Collaborate with stakeholders; report on status of equipment, facility, systems
Act as QA SME during client/regulatory inspections
Drive continuous improvement, efficiency, and productivity

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