Ability to interpret technical drawings, specifications, and industry standards, and to align production processes with customer and regulatory requirements.
Demonstrated leadership skills, including team management, cross-functional collaboration, and training or mentoring of staff on quality topics.
Strong analytical and problem-solving abilities, with attention to detail and a structured approach to resolving quality issues.
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Manage and follow up on deviations, investigations, CAPA, change controls, and quality risk assessments.
Participate in root cause analysis and investigation of quality issues and ensure appropriate corrective and preventive actions are implemented effectively.
Conduct GMP and quality system inspections/audits and support follow-up of audit observations and commitments.
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Assisting the management and implementation of the strategic planning for QA unit
Ensuring and accountable for the university compliances with the policies and regulations by the professional bodies, stakeholder and institution authorities
Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
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Execute work and present its findings to the client and their stakeholders
Anticipate and identify risks and escalate issues as appropriate
Work closely with colleagues, determine whether the work plan is properly executed, documented and concluded in compliance with Quality & Risk Management guidelines
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Clearly and accurately document the execution of specific audit procedures as defined by the engagement objectives, audit client's engagement history, and planned audit approach
Recognize potential audit issues or unusual relationships from basic analysis of the financial statements and communicate them to the assurance team
Assisting the management and implementation of the strategic planning for QA unit
Ensuring and accountable for the university compliances with the policies and regulations by the professional bodies, stakeholder and institution authorities
Clearly and accurately document the execution of specific audit procedures as defined by the engagement objectives, audit client's engagement history, and planned audit approach
Recognize potential audit issues or unusual relationships from basic analysis of the financial statements and communicate them to the assurance team