Internal Audit and External Audit
Responsible for the effective controlling of document system as per WI/GMP/ISO requirement, all supported document and training record Review and check the document control SOP, SPEC and WI
Conduct all the NCR with correct CAPA and sent back to RA/QA department after written by the respective department in charge.
Implement QA system and liaise with operation personnel to improve product quality
Training of QA Supervisor, QA Line Leaders and QA Inspector to upgrade their Job knowledge
Performing assignment as required on daily basic.
Responsible for the effective controlling of document system as per WI/GMP/ISO requirement, all supported document in Operation and training record Review and check the document control SOP, SPEC and WI in Operation area.
To ensure compliance to Kimberly Clarks Mission, Vision, Values and all company policies, procedures and corporate ethics.
At all times support Kimberly-Clark Environment, Health and Safety Management by actively participating in loss control activities,
o To prevent injuries and major losses as well as achieve our major goals such as zero fatalities, permanent disabilities and repeat injuries.
o To protect our property and make a safe, healthy and environment and to prevention of pollution as business value.
Control and maintain operations documentation; e.g. SOP, WI, SPEC, Job Description, Organization, Job template. This job responsibility includes performing documentation audits with respective department.
Ensure all documentation are up to date and at the correct revision.
Process and coordinate on document change according to QSI system for operations.
Support operations team to conduct CAPA process, review and analysis root cause and ensure the timely close out for CAPA in TrackWise system.
Provide Operations team with adequate training and support in the use of TrackWise system.
Responsible for the effective controlling of document system as per WI/GMP/ISO requirement, all supported document and training record Review and check the document control SOP, SPEC and WI
Conduct all the NCR with correct CAPA by the respective department in charge.
Implement QA system and liaise with operation personnel to improve product quality
Training of QA Supervisor, QA Line Leaders and QA Inspector to upgrade their Job knowledge
Performing assignment as required on daily basic.
ประวัติการฝึกอบรม
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TÜV SUD
Medical Devices-Quality Management Systems -Requirements for Regulatory Purposes. (ISO 13485: 2016)
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TÜVRheinland
Quality Management Systems- Requirements. (ISO 9001: 2015)