RELATIONSHIPS

• Reporting to Head of Quality, Compliance and Ethics
• Work closely with Quality & Compliance Team, Senior Management and Implementation Staff

POSITION PURPOSE

The Quality Associate is responsible for upholding Axios policies and procedures, ensuring the implementation and effective applying of the quality standards.

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