· Support the implementation of quality management systems (QMS), policies, procedures, and work instructions.
· Ensure new processes, systems, or products meet defined quality and compliance requirements before and after launch.
· Collaborate with cross-functional teams to integrate quality standards into daily operations.
· Monitor implementation effectiveness and recommend corrective actions where gaps are identified.
· Plan, conduct, and document internal audits to assess compliance with company standards, regulatory requirements, and industry best practices.
· Support external audits and regulatory inspections, including preparation, coordination, and follow-up actions.
· Track audit findings, non-conformances, and corrective/preventive actions (CAPA) to closure.
· Maintain audit records and quality documentation in accordance with established guidelines
· Analyze audit results, quality metrics, and trends to identify risks and improvement opportunities.
· Participate in root cause analysis and support the development of effective corrective and preventive actions.
· Provide guidance and training to staff on quality standards, audit readiness, and best practices.
· Contribute to continuous improvement initiatives to enhance process efficiency and quality performance.