Job details

Quality Associate

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

Relationships

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

• 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

Competitive Salary

Training and Development

Career Progression

International Exposure

Healthcare

Average salary estimate

$70000 / YEARLY (est.)

min

max

$60000K

$80000K

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What You Should Know About Quality Associate, Axios International Consultants Ltd

At Axios, we're excited to welcome a new Quality Associate to our dynamic team! This role is all about maintaining our high-quality standards and ensuring that everything runs smoothly within our processes. As a Quality Associate, you will be responsible for reviewing deviation investigations, managing complaints, and executing corrective actions that enhance our operations. You’ll play a crucial role in maintaining our Documentation Control, ensuring that our Management System Documentation is always up to date and compliant. If you've got experience in supplier management, your skills will shine in supporting supplier evaluations and keeping our supplier lists accurate. You’ll also get involved in monitoring quality audits, documenting our quality assurance activities, and assessing operational risks. Your analytical skills will be put to the test as you help develop strategies to enhance our quality processes. Collaboration is key in this role, as you will be reporting to the Head of Quality, Compliance, and Ethics while working closely with the Quality & Compliance Team. This is an amazing opportunity to contribute to our mission of excellence while gaining valuable training and exposure in the healthcare industry. If you have a passion for quality and compliance and bring 3+ years of experience in the healthcare service sector, we’d love to hear from you. Join us and take the next step in your career with Axios, where we value growth, training, and development for all our associates!

Frequently Asked Questions (FAQs) for Quality Associate Role at Axios International Consultants Ltd

What are the primary responsibilities of a Quality Associate at Axios?

As a Quality Associate at Axios, you'll be responsible for reviewing deviation investigations, managing complaints and non-conformities, and implementing corrective actions. You'll maintain quality documentation, assist with supplier evaluations, and support internal and external audits, all while documenting quality assurance activities effectively.