Quality Assurance Specialist

3 days ago


Thành phố Hồ Chí Minh, Vietnam Trung Tâm Y Khoa Diag Full time

_JOB DESCRIPTIONS:_

**1. Document control and record (50%)**:

- 1.1. 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)._1.2. Record control _**(20%)**:

- Collect data and information to make records related to ISO 15189:2022.
- Arrange the records according to procedures._1.3. Ad-hoc document review _**(10%)**:

- Receive the request from Lab or other departments to update the SOPs/QSPs.
- 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. Support QA team and related departments in external audit (ISO, DOH,) and Internal audit with QA Head (20%)**:

- 2.1. External audit (ISO audit, DOH audit, Polyclinic audit, ) _**(15%)**:

- Co-ordinate with related team to compose the procedures align with ISO standard, 2429 decision from DOH.
- Attend the audits and support arrange files for QA team._2.2.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.
**3. External Quality Control Program (20%)**:

- 3.1. Sample receive and distribution_- Receive sample from vendors.
- Checking the quality of specimen (Lot/date, temperature, quantity)
- Handover to related departments
- Fill records.
- 3.2. Result submission_
- Checking raw data and result sheet
- Submit data on portal.
- 3.3. Result evaluation_- Receive evaluation report from portal --> analyze result.
- Arrange the hard copy and soft copy.
- 3.4. Corrective action and preventive action_
- Identify the outlier in the evaluation report and notify to department for CAPA.
- Review the CAPA and follow up with evidence.
- Tracking CAPA.
**4. Training (10%)**:

- Prepare material and assessment sheet to topic assigned by QA Head.
- Conduct the training and evaluate the assessment after training. Arrange training records.
- JOB REQUIREMENTS:_
- At least 1 year of experience in quality assurance of medical.
- At least 1 year of experience in medical laboratory.
- Graduated major related to Medical. Good computer skills MS Office (Word, Excel, PowerPoint).
- Can communicate in English and read document in English.
- Good in documentation and good grasping power.
- Good time management in completing tasks. Team work attitude and critical thinking.

Pay: 16,000,000₫ - 18,000,000₫ per month



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