Quality Associate

Position Purpose

The Quality Associate is responsible for upholding Axios policies and procedures, ensuring the implementation and effective application 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 records
• 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 staff training on Quality related topics
• Follow up on the implementation and the progress of the training plan
• Support in developing the training needs 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

Requirements

• 3+ years proven experience working within Quality Assurance department based within Healthcare or Service Industry
• Bachelor's degree in a related discipline with proven experience working on IT systems
• Knowledge of audit, compliance and quality assurance terminology, methods, and tools
• Demonstrated knowledge of testing best practices, version control practices and defect management practices
• Analytical, problem-solving, and decision-making skills
• Fluent in Arabic and English
• Certificate in Audit practices is a plus

Benefits

Competitive Salary
Training and Development
Career Progression
International Exposure
Healthcare