Clinical Quality Specialist
Takeda
Posted
last week
Mumbai, Maharashtra, India
Onsite
INR 75K
Mid Level
Full Time
Sema Summary
The Sr Clinical Quality Specialist at Takeda manages the clinical quality function, ensuring compliance with trial regulations and internal quality systems. The role involves collaboration with various stakeholders to maintain quality standards throughout clinical operations.
About Company
Takeda is a global pharmaceutical company focused on transforming patients' lives through innovative medicine. With over two centuries of experience, the company emphasizes its core values of patient-centricity and scientific excellence.
Core Requirements
- Life Sciences Graduate/Postgraduate
- 7-10 years of experience in clinical trial industry
- Experience as a Clinical Quality Auditor
- Strong communication skills
- Ability to work independently and identify compliance risks
Responsibilities
- Manage clinical quality function and compliance.
- Develop and implement quality assurance procedures.
- Conduct internal and external audits for clinical trials.
- Provide oversight for GCP suppliers and agreements.
- Initiate and escalate quality incident reports.
- Support deviation and incident management processes.
- Maintain local Quality Management System.
Must Have skills
Job Keywords
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