Core Responsibilities:
• Define and implement the site specific Quality Plan to meet the requirement of ISO, GMP, MCC, Halal , TGA PICs, USFDA, Colgate Quality Standards and other relevant requirements.
• Contribute to Quality Standards & Guidelines updates/ enhancement. Define applicable areas of focus, timelines, resources requirement to drive implement of Quality Standards & Document Control System.
• Lead Quality Training program, Quality Internal Audit program and Quality documentation control system to ensure effectiveness and compliance to Quality Standard and regulatory requirement.
• Facilitate external audit and ensure compliances with local and CBS quality related regulatory requirement.
• Support Quality Management Representative (QMR) in ISO system and coordinate with Management to ensure quality system is in place. Also update Management Committee for all quality related issues and action plan.
• Lead / participate in Division and /or Local Quality Audits. Provide assistance in closing audit observations.
• Evaluate statistical data; participate on cross-functional teams and special projects.
• Consumer /Customer Complaint and CRS database handling.
• Support site change control process.
• Coordinate for Annual Products Review for regulated products.
• Perform other duties and responsibilities as assigned.
Authorities/ Decisions:
• Conduct performance evaluation of Support Technician.
• Monitoring, closing, and reporting corrective action/preventive action (CA/PA) from Quality Internal audit and GMP monthly inspection and CRS database.
• Manage and monitor routine operation as per work procedures, policy, audit FAP, and etc.
Magnitude of Responsibility:
• Supervise & coach support technicians both quality system and document control technician.
• Responsible for compliance of quality management system of chemical lab and micro lab operation of BPK site with corporate & local requirement.