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Quality Assurance Manager
2 weeks ago
Quality Specialist - Change Control System
About the Role:We are seeking a highly organized and detail-oriented Quality Specialist to manage the Change Control System. This role involves overseeing the documentation, review, and approval of change requests, analyzing risk assessments, and ensuring compliance with regulatory standards.
Key Responsibilities:- Manage the change control process, ensuring all change requests are documented, reviewed, and approved.
- Analyze risk assessments for proposed changes and identify potential impacts.
- Coordinate updates to documents and training as needed.
- Maintain accurate records throughout the change control process.
- Collaborate with teams across the organization to ensure smooth change implementation.
- Support FDA inspections and external audits by providing required documentation.
- Continuously review and improve the change control process to maintain quality standards.
- Ensure compliance with regulatory standards and internal policies.
