Compliance

• Providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team.
• Support HA reporting (FAR, BPDR, OUS requirements).
• Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries.
• Lead inspection readiness activities.
• Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
• Work with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements.
• Support the coordination of the execution activities related to US product recall and withdrawals.
• Participate in periodic product withdrawal/recall simulations.
• Consult and train local recall coordinators to assure understanding of process for product removal.
• Monitor recall activities of partner organizations globally.
• Provide information for use in various periodic reviews or metrics.

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