GMP Auditor

• Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements and industry standards.
• Conduct audits and inspections of facilities, processes, and documentation to assess compliance and identify areas for improvement.
• Review and approve quality-related documentation, including standard operating procedures (SOPs), change controls, and validation protocols.
• Ensure that all quality assurance activities adhere to relevant regulatory guidelines, including FDA, EMA, and GMP standards.
• Maintain and update quality assurance documentation, including audit reports, corrective and preventive action (CAPA) plans, and deviation reports.

In addition, you will assist in the preparation of regulatory submissions and responses to regulatory agency inquiries, investigate quality issues, deviations, and non-conformities, and implement corrective and preventive actions to address and resolve them.