Quality Assurance

1 week ago

Singapore IGENE LABORATORY PRIVATE LIMITED Full time

1. Identifying training needs and ensuring testing personnel receive regular in-service training, and participate in continuing education and in-service programs.

2. Prepare regulatory dossier for MOH, HSA, CAP and other regulatory bodies related submissions.

3. Verify the Lab Director’s review of monthly QC, maintenance, patient records, and QA monitors.

4. Develop policies and procedures for molecular-based clinical diagnostic assays/tasks according to established operational procedures.

5. Update, revise, and maintain the Laboratory’s Quality Assurance Manual, SOPs, and other quality documents.

6. Responsible for enrolment and development of the laboratory in an approved EQA program, work with Laboratory Director on implementing the program and ensure that the program is followed.

7. Maintain complete documentation for assay tracking and results for review/reporting.

8. Perform internal audits of the Laboratory, including both technical and quality systems audits.

9. Perform and document corrective action, including follow up monitoring to gauge the effectiveness of the correction action.

10. Maintain the Laboratory’s Quality System.

**Skills**:

- Excellent in communication and writing
- Have participated & involved in regulatory audits such as MOH, SAC-SINGLAS or CAP (College of American Pathologists)

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