Quality Assurance Professional
2 weeks ago
This is a unique opportunity to work in a high-performing Quality Assurance environment.
**About the role**
The Quality Assurance Associate will support the development, implementation, and maintenance of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations.
**Key Responsibilities**
- Conduct internal study audits to verify compliance with regulatory requirements and organisational procedures.
- Perform internal process audits to ensure adherence to internal processes and applicable regulatory standards.
- Assist with vendor audits and audits conducted by sponsors as required.
- Contribute to the investigational team for CAPAs as needed.
- Coordinate preparation, review, and issuance of Standard Operating Procedures (SOPs) to support quality systems.
- Stay up-to-date with the latest GCP and regulatory requirements.
**Qualifications and Requirements**
- Bachelor's degree in a life science field.
- Minimum 2 years' experience in Quality Assurance with ICH-GCP training and knowledge of clinical trials from a non-manufacturing perspective.
- Formal audit training or evidence-based internal / study audit training.
- Intermediate MS Office suite skills.
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