Assess operational risks and implement mitigation strategies to support business continuity and manufacturing resilience.
Support internal and external audits and ensure adherence to established manufacturing standards.
Ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company policies relating to Quality, Environmental Health & Safety (EHS), and operational excellence.
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Good business acumen with the ability to identify customer pain points, understand commercial drivers, position service value, and build recurring revenue opportunities.
Good working knowledge of managed IT services, including helpdesk support, preventive maintenance, endpoint support, server and network support, cloud services, backup, SLA, escalation models, and service reporting.
Able to understand customer technical environments at a high level and translate service requirements into clear business discussions, without being responsible for technical delivery.
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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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