Position: 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 and distribution of the Management System Documentation

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

Relationships

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

Special Skills and Knowledge

• Collaboration
• Independence and autonomy
• Good critical thinking skills
• Good relationship-building skill
• Teamwork ability, to assist others in a friendly and efficient manner
• Ability to communicate effectively, both verbal and written, with all internal organization departments, suppliers, subcontractors, and regulatory authorities.
• Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor

Competencies

• Results Orientation
• Problem Solving
• Application of Job Knowledge
• Concern for Order and Quality
• Integrity and Ethics
• Strong attention to detail

Educational Background and Experience

• Bachelor\xe2\x80\x99s degree
• Proven knowledge of quality assurance terminology, methods, and tools
• Demonstrated knowledge of testing best practices, version control practices and defect management practices
• 1-2 years\xe2\x80\x99 experience in Quality is a plus.
• Analytical, problem-solving, and decision-making skills
• Certificate in Quality Assurance is a plus
• Fluency in English (written and oral)

Job Circumstances

• This is a full-time position
• Flexibility in working hours is essential

Axios International