The opportunity
Inspection Readiness Expert with extensive experience in audit and compliance within the pharmaceutical industry.
Responsible for ensuring site readiness and regulatory compliance by overseeing and managing audits, assessing vendor compliance, and providing remediation actions.
This role requires a deep understanding of regulatory requirements and Pharmaceutical standards, as well as the ability to effectively prepare and review risk assessments and Corrective and Preventive Actions (CAPA).
How you’ll spend your day
Evaluate vendor and site compliance, including reviewing risk assessments of audit deficiencies, corrective and preventive actions, and overall compliance status.
Develop and monitor the implementation of remediation actions to address audit findings and ensure ongoing compliance.
Communicate potential risks and impacts related to site observations and GMP deficiencies to relevant stakeholders.
Prepare and review risk assessments and CAPA plans based on audit results and site observations.
Support the process for notifying management of critical and major findings
Regularly participate in internal and external training sessions to stay current with industry standards and best practices.
Must be able to travel approximately 50% of the time.
