QA Specialist

Key Job Purpose :

• A Quality Management Representative and Designated Person who will be in charge of Quality Management system.
• Co-ordinator and lead for follow up of RHQ internal audit findings to ensure all action plan has been done on time.
• Re-check all previous RHQ internal audit finding and prevent for all recurrence.

Job Description :

1. Management Representative for ISO 9001 and Designated Person for QMR
2. Appointed as Management Representative for ISO 9001 and designated person for the Company.
3. Ensuring processes needed for quality management system is established, implemented and maintained.
4. Reporting on the performance of the quality management system including needs for performance improvement in management review meeting.
5. Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.
6. Liaising with external parties on matters relating to the quality management system
7. Administering and coordinating document control system, internal audits, external audit and management review for Sysmex (Thailand) Co., Ltd.
8. Follow-up with Team Managers to ensure closure of the corrective action plans for Non-Conformity and Observations/Opportunity Improvements (if any).
9. Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
10. Handling FCA and FSCA information from RHQ QA and provide information with document to business partner & customer, submit all information to Thai FDA.
11. Ensure all redressing and all product label provided by marketing people are correct and comply with Thai FDA regulation.

Job Specification :

• Bachelor Degree of Science or equivalent
• Minimum experience 2-3 years in a science/technical role in the healthcare industry (R&D, Clinical or other technical function).
• Knowledge in ISO 9001, FCA/FSCA.
• Excellent verbal and written communication skills.
• Good command in English Skill.
• Attitude Required :            Responsible, team player, keen to learn
• Healthcare industry experiences with in-vitro diagnostics will be advantage.