Quality Assurance Executive

Summary:

Job Responsibilities:

1. Document Control:

   Assist in maintaining and organizing quality documentation, including Quality Manual, Documented Procedures, Standard Operating Procedures (SOPs), and forms.

2. Internal Audits:

   Participate in internal audits of various departments to assess compliance with the Quality Management System (QMS) and report findings to senior QA staff.

3. Non-Conformance Management:

   Support the investigation of non-conformities or deviations, aiding in root cause analysis and the development of corrective and preventive actions (CAPAs).

4. Change Control Support:

   Assist in the change control process, including reviewing change requests and assessing their potential impact on quality and compliance.

5. Risk Management Assistance:

   Collaborate with senior QA staff in performing risk assessments and assisting in the implementation of risk management strategies.

6. Product and Process Validation Support:

   Participate in product and process validation activities, ensuring that they meet specified requirements.

7. Complaint Handling Support:

   Assist in the review and resolution of customer complaints related to product quality.

8. Corrective and Preventive Action (CAPA) Support:

   Support CAPA processes by helping to gather data and track the progress of corrective actions.

Education and Experience

• Bachelor’s / Master's degree in life science background.
• 1 to 3 years of relevant experience preferred in a similar role in IVD industry.

hr3@athenesedx.com