Quality Assurance - Singapore - IGENE LABORATORY PRIVATE LIMITED
Description
1. Identifying training needs and ensuring testing personnel receive regular in-service training, and participate in continuing education and in-service programs.- Prepare regulatory dossier for MOH, HSA, CAP and other regulatory bodies related submissions.
- Verify the Lab Director's review of monthly QC, maintenance, patient records, and QA monitors.
- Develop policies and procedures for molecular-based clinical diagnostic assays/tasks according to established operational procedures.
- Update, revise, and maintain the Laboratory's Quality Assurance Manual, SOPs, and other quality documents.
- 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.
- Maintain complete documentation for assay tracking and results for review/reporting.
- Perform internal audits of the Laboratory, including both technical and quality systems audits.
- Perform and document corrective action, including follow up monitoring to gauge the effectiveness of the correction action.
- 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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