Quality Assurance Specialist (Medical Lab)

Document control and record (50%)
1.
Document control
(20%)
- Review procedure + revise procedure (English and Vietnamese version) according to
ISO 15189: 2022
standard and DOH regulations related to medical fields.
- Issue new procedure to related department (arrange hard copy and soft copy).
- Obsolete the old version of procedure (arrange file hard copy and soft copy).
2.
Record control
(20%)
- Arrange the records according to procedures.
- Collect data and information to make records related to ISO 15189:2022.
3.
Ad- hoc document review
(10%)
- Issue new procedure to related department (arrange hard copy and soft copy).
- Obsolete the old version of procedure (arrange file hard copy and soft copy).
- Receive the request from Lab or other departments to update the SOPs/QSPs.
Support QA team and related departments in external audit (ISO, DOH, …) and Internal audit with QA Head (20%)
1.
External audit (ISO audit, DOH audit, Polyclinic audit,…)
(15%)
- Attend the audits and support arrange files for QA team.
- Co- ordinate with related team to compose the procedures align with ISO standard, 2429 decision from DOH.
2.
Internal audit (Laboratory)
(5%)
- Monitoring the corrective action and support to propose preventive action for NCs to department in charge.
- Support to translate and explain the non- conformities for departments and person in charge during audit.
External Quality Control Program (20%)
1.
Sample receive and distribution
- Checking the quality of specimen (Lot/date, temperature, quantity)
- Handover to related departments
- Receive sample from vendors.
- Fill records.
2.
Result submission
- Checking raw data and result sheet
- Submit data on portal.
3.
Result evaluation
- Arrange the hard copy and soft copy.
- Receive evaluation report from portal analyze result.
- Input data to monitor on excel sheet + email to Lab.
4.
Corrective action and preventive action
- Review the CAPA and follow up with evidence.
- Tracking CAPA.
- Identify the outlier in the evaluation report and notify to department for CAPA.
Training (10%)
- Arrange training records.
- Conduct the training and evaluate the assessment after training.
- Prepare material and assessment sheet to topic assigned by QA Head.

- At least 1 year of experience in quality assurance of medical.
- Good time management in completing tasks.
- At least 1 year of experience in medical laboratory.
- Good in documentation and good grasping power.
- Graduated major related to Medical.
- Can communicate in English and read document in English.
- Good computer skills MS Office (Word, Excel, PowerPoint).
- Team work attitude and critical thinking.

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Cập nhật gần nhất lúc: 2024-11-14 17:10:03