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Manager, CAPA
Exela Pharma Sciences
Lenoir, USA
Full-time
Mid · 5+ years experience
Onsite
Discovered 1 weeks ago
Free
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The CAPA Manager plays a pivotal role in ensuring that organizational CAPA initiatives are executed with the highest standards of quality and efficiency within the sterile pharmaceutical manufacturing environment. This position is responsible for developing, implementing, and overseeing quality assurance processes that support CAPA including Quality Action Report (QAR) and Event Report investigation management strategies, ensuring alignment with business objectives and regulatory requirements. The role requires close collaboration with cross-functional teams to monitor the impact of CAPA implementation, mitigate risks, and drive continuous improvement. The CAPA Manager will lead efforts to establish metrics and reporting mechanisms that provide transparency and accountability throughout the CAPA lifecycle, ensuring that CAPA initiatives deliver intended benefits while maintaining operational excellence and stakeholder satisfaction.
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Position Summary
The CAPA Manager plays a pivotal role in ensuring that organizational CAPA initiatives are executed with the highest standards of quality and efficiency within the sterile pharmaceutical manufacturing environment. This position is responsible for developing, implementing, and overseeing quality assurance processes that support CAPA including Quality Action Report (QAR) and Event Report investigation management strategies, ensuring alignment with business objectives and regulatory requirements. The role requires close collaboration with cross-functional teams to monitor the impact of CAPA implementation, mitigate risks, and drive continuous improvement. The CAPA Manager will lead efforts to establish metrics and reporting mechanisms that provide transparency and accountability throughout the CAPA lifecycle, ensuring that CAPA initiatives deliver intended benefits while maintaining operational excellence and stakeholder satisfaction.
Job Responsibilities
- Develop and maintain comprehensive quality management frameworks tailored to CAPA management processes.
- Collaborate with project managers, business analysts, and stakeholders to define quality standards and success criteria for CAPA initiatives.
- Conduct regular audits and assessments to ensure compliance with established quality standards and identify areas for improvement.
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