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Quality Excellence Specialist
$ 5,500 - $ 6,000 / month
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About the role:
We are seeking a Quality Excellence (QE) Specialist to support Deviation Management and Change Control Management System (CCMS) at Takeda. This role is critical in ensuring compliance with regulatory requirements and internal quality standards across various functions, facilitating continuous improvement and risk mitigation.
Responsibilities:
- Assess, review, and approve change control requests to ensure compliance with regulatory and Takeda quality standards.
- Collaborate with cross-functional teams to evaluate potential risks and impacts of changes on product quality and operational processes.
- Conduct thorough reviews and approvals of site investigations and deviations across multiple functions (Manufacturing, Engineering, Validation, Logistics, Supply Chain Planning, Laboratories, and Incoming Material Release).
- Ensure root cause analyses are performed effectively and that corrective/preventive actions are identified and implemented.
- Maintain detailed records of deviations and ensure timely closure in alignment with compliance requirements.
- Review and approve CAPAs related to deviations, ensuring corrective actions effectively address root causes and prevent recurrence.
- Monitor CAPA effectiveness and follow up with stakeholders to drive continuous improvement.