Responsibilities

• Serve as a representative of the Internal QMS Audit Team.
• Independently lead/participate in compliance audits and identify compliance gaps or risks
• Provide special/unique products and components knowledge 
• Work with customers/suppliers to ensure that the site set the critical and unique quality standards in compliance with FDA/regulatory requirement for the manufacturing services.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Provide audit compliance expertise to internal and external customers.
• Train QA Staff on quality related SOP/WI and ISO9001/13485, cGMP or US FDA 21 CFR Part 820 requirements.
• Lead respective QA teams and work with HOD to meet site KPI targets and customers’ quality requirement.

Other Responsibilities

• Lead on matters concerning the development, maintenance and monitoring of effectiveness of the Quality System.
• Initiate actions to prevent the occurrence/ recurrence of product non-conformity and system deficiency.
• Investigate into any product non-conformance or matters affecting the Quality System.
• Drive cross functional teams towards meeting: (1) site KPI targets and (2) customers’ quality targets and requirements, for example, as stated in the Quality Agreement and Quality Management Plan.
• Support NPI to build a robust quality assurance process.
• Generate quality plans, control plans, procedures, work instruction for overall quality.
• Coordinate on effective implementation of such plans, procedures or instructions for compliance with regulatory requirement (e.g. 21 CFR Part 820) and conformance to ISO 9001/13485/14001/customer’s requirements in the manufacture of life science or medical devices.
• Facilitate in the internal FDA Program Committee Meetings and act as a subject matter expert for the GMP Compliance Audit team.  
• Partner closely with key stakeholders to lead and implement periodic GMP compliance audits for the site.