We seek a highly experienced and detail-oriented QA Change Manager to lead and own the end-to-end Change Control Process at Synnat Pharma, a rapid-growing leader in API manufacturing. At Synnat, we have made the Change Management QMS System the strongest and most influential management system, impacting everything the organization does. With 10+ years in Quality Assurance, you will be instrumental in ensuring cGMP Compliance, integrating Quality Systems, and conducting robust Risk Assessments for all changes.
This pivotal role offers a unique opportunity to drive Continuous Improvement, enhance Change Effectiveness, and champion Cross-functional Collaboration across our Semi-regulated, Non-regulated, and regulated markets. If you are passionate about Regulatory Change Management and aspire to shape quality excellence in a dynamic pharmaceutical environment, we invite you to apply and advance your career with us.
Roles & Responsibilities:
Change Management
1. Lead the end-to-end change control process across all relevant departments.
2.
Assess all proposed changes for impact on cGMP compliance, quality, and regulatory requirements.
3. Coordinate review and approval of change requests with cross-functional teams.
4. Maintain comprehensive documentation for all change control activities, ensuring audit readiness.
5. Ensure all change management activities strictly adhere to cGMP guidelines and Synnat Pharma's QMS.
6. Link the change control process with other quality systems like CAPA and Deviation management.
7. Conduct thorough risk assessments for all proposed changes and implement mitigation strategies.
8. Develop and implement metrics to monitor the effectiveness of implemented changes.
9. Provide training and guidance to personnel on change control procedures and cGMP requirements.
10. Communicate effectively with senior management on the status of significant changes and potential risks.