You are responsible for
Ensures compliant and effective QMS’s are maintained in scopeManage Q&R processes and ensure process ownership for all activities under PQMS governance in scopeEnsures Q&R requirements are effective in all processes in scope
Leading KGMP project for recertification and site change, also regulatory monitoring related to KGMP regulation.
Maintaining annual schedule for Health Tech (Medical Device & Consumer sectors) annual master plan such as internal audit, imported device reporting, repair performance reporting and KGMP on-site audit schedule.
Maintaining business license with company profile through Change Control process.
Maintaining effective document and training matrix.
Managing and monitoring employee training.
KPI monitoring and action driving to SMEs