Quality Assurance Specialist (ISO 15189)

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%)
- Support to translate and explain the non- conformities for departments and person in charge during audit.
- Monitoring the corrective action and support to propose preventive action for NCs to department in charge.
External Quality Control Program (20%)
1.
Sample receive and distribution
- Receive sample from vendors.
- Checking the quality of specimen (Lot/date, temperature, quantity)
- Fill records.
- Handover to related departments
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.
- Identify the outlier in the evaluation report and notify to department for CAPA.
- Tracking CAPA.
Training (10%)
- Conduct the training and evaluate the assessment after training.
- Prepare material and assessment sheet to topic assigned by QA Head.
- Arrange training records.

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

Laptop, Chế độ bảo hiểm, Phụ cấp, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Nghỉ phép năm

Cập nhật gần nhất lúc: 2024-11-28 12:15:03