Regulatory update including export market and local regulation monthly update, other reports once required (global FSQ reports, MOR report…)
Standardization/ Optimization: new SOPs, Testing methods, frequency, work with service to help sites can find to solution for improve.
Collect data from the sites, (e.g. KPI tracking report, customer complaint, CAPA, testing, cost, Certification status report, FSVP status report, FDA registration status report, …) do analysis, reporting monthly, quarterly, yearly or depend on top management request.
QMS: follow guideline of QFS manager to prepare SOP, collaboration with sites to develop, implement and maintain QMS system follow global STD, GFSI standard, customer expectation to all sites and following up on executions.
FDA Alert monthly report /RASFF monthly report
Surveys (FSQ culture, polls, other projects…).
Set up FSQ meeting with all sites in Regional; Critical complaint meetings with site management team to solve the issue (escalated cases); Cascading meetings with all sites to deploy FSQ plans; Other meetings as needed (sharing & learning calls, training sessions, …) recording MoM, following up on aligned action plan.
Supporting audits (certification audits, customer audits) when required providing required documents to support the audit, participating audits to help team answering tough questions from auditors, joining closing meeting to influence the auditor decisions.
Regulatory review in conjunction with NPD team in new product projects
Authority:
Reporting to Central QFS Manager regarding QMS performance and suitability action for improvement.
Deploy QMS system. Support QFS management system is established, implemented, maintained, and continued improvement.
Coordinate with QFS manager of sites to collect & check correct data, analysis and report on time.
Independent in implementing assigned tasks and complying with company regulations.
To support QFS Manager:
Developing, applying, maintaining, and continuing improvement of the quality management system.
Collecting data from the site, making reports, analysis data.
