משרות תוצאות חיפוש מתאימות לבקשתך:

The opportunity
Inspection Readiness expert with extensive experience in both Quality Control (QC) and Quality Assurance (QA). This role involves ensuring site readiness and regulatory compliance by assessing vendor compliance and providing remediation actions.
The candidate must possess a deep understanding of regulatory requirements, and QC practices, including analytical methods, specifications, method validation, Lab Instrument qualification and calibration, 21 CFR regulations, data integrity.

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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.
Leverage QC expertise to ensure robust quality control systems and compliance at suppliers.
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