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Biotech Quality Assurance Manager
2 weeks ago
Job Summary:
\We are seeking a skilled professional to fill the role of Biotech Quality Assurance Manager.
\About the Position:
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- Develop and maintain quality systems, ensuring compliance with relevant regulations.\
- Provide quality direction at Change Control and Deviation Review Boards.\
- Oversight of change control and Deviation/CAPA records.\
- Stay up-to-date on regulatory initiatives and new guidance/requirements.\
- Implement sustained compliance initiatives, including execution of gap assessments.\
- Oversight and management of Quality Risk Management (QRM) Processes.\
- Trend programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM.\
- Challenge current procedures and practices, interpret trend data.\
- Ensure effective implementation of self-inspection, audit, and key compliance systems.\
- Development and maintenance of documentation management systems.\
