Quality Associate
4 weeks ago
**Position Purpose**
**Duties and Responsibilities**
Complaint_, Deviation, Non-Conformity, and CAPA:_
- Review deviation investigations and actions as required including corrective action and continuous improvement implementation
- Issue non-conformity reports, carefully maintain complaint and non-conformance processing through records and tracking systems, including root cause and corrective actions
- Update Complaint & CAPA reports and registers
- Follow up with staff on the CAPA implementation progress.
- Documentation Control_
- Ensure control of the Management System Documentation and recorded
- Conduct all program activities through exclusive use of Axios’ Patient Management System (PMS)
- _Supplier Management _
- Support in executing the Supplier and Third-Party Evaluation process
- Update supplier approved list according to the evaluation result.
- Follow up with suppliers and third parties for the required documentation as part of the evaluation process
- Monitoring_
- Support the Quality & Compliance Team with internal and external audits.
- Conduct internal Quality reviews and monitor audit activities within department deadlines.
- Document Quality Assurance activities with internal reporting and audits.
- Assess operational risks, develop strategies, and plans for risk management.
- Support in the implementation of the Operational Control Measures (Quarterly Quality Assurance, Source Data Verification Exercise).
- Monitor staff handover documentation.
- Certification_
- Provide support to Quality & Compliance Team in obtaining certifications and accreditations
- _Training_
- Assist in Providing the staff training on Quality related topics.
- Follow up on the implementation and the progress of the training plan
- Support in the developing of the training need analysis and training evaluation
- Other_
- Attending and completing Pharmacovigilance, Pharma and Product Training provided by the Client with a clear understanding of how to collect and report safety data
- Reporting any adverse events/product complaints as per client’s requirements and/or Axios SOPPs
- Additional duties as assigned
**Relationships**
- Reporting to Head of Quality, Compliance and Ethics
- Work closely with Quality & Compliance Team, Senior Management and Implementation Staff
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