QA Specialist
QA Specialist
Sysmex Asia Pacific- Posted an hour ago
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Job Description
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.
- Management Representative for ISO 9001 and Designated Person for QMR
- Appointed as Management Representative for ISO 9001 and designated person for the Company.
- Ensuring processes needed for quality management system is established, implemented and maintained.
- Reporting on the performance of the quality management system including needs for performance improvement in management review meeting.
- 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.
- Liaising with external parties on matters relating to the quality management system
- Administering and coordinating document control system, internal audits, external audit and management review for Sysmex (Thailand) Co., Ltd.
- Follow-up with Team Managers to ensure closure of the corrective action plans for Non-Conformity and Observations/Opportunity Improvements (if any).
- Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
- Handling FCA and FSCA information from RHQ QA and provide information with document to business partner & customer, submit all information to Thai FDA.
- Ensure all redressing and all product label provided by marketing people are correct and comply with Thai FDA regulation.
- 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.
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