JOB DETAILS

JOB DETAIL

- Provide necessary training to organization for quality system, GMP for medical device and 21CFR part 820
- Control and maintain document control system within organization (for example, batch records, sterilization reports, and any controlled documents etc.)
- To have coordination with QMR to manage internal and external audit of subcontractor and supplier within organization.
- Manage and control of customer complaint handling including investigation and analysis.
- Maintain master lists of non-conformities, validate their analysis and follow the progress of their corrective and preventive action.
- Maintain and follow up of the corrective action from the decision to open them to the follow-up of their progress and evaluation of their effectiveness.
- Manage product’s shipment and QA release as well as product’s certificate for customers.
- Release of products has the authority to release orders of finished products including certification of conformity on product approval
- Follow up and maintain Monthly report.

REQUIRED WORK EXPERIENCE

- Bachelor degree in Science or Engineering
- Minimum 8 years in QC or QA, especially in medical device or pharmaceutical product will be plus
- Computer literacy (excel, word, power point)
- Fluent in spoken and written in English.