Lead and coordinate internal audits to verify compliance with GMP, company SOPs, and quality standards. Ensure audit schedules are executed, findings are documented, and CAPAs are effectively closed within defined timelines, driving continuous improvement across processes.
Plan, conduct, and follow up on vendor audits to ensure suppliers and contractors meet company and regulatory requirements. Communicate audit outcomes promptly to vendors, track closure of corrective actions, and promote supplier quality improvement.
Ensure site readiness for regulatory inspections and external audits at all times. Lead preparation activities, coordinate on-site support during audits, and ensure timely and accurate CAPA responses to regulatory authorities, with a focus on sustaining long-term compliance.
Coordinate and track follow-up of audit findings to ensure corrective and preventive actions are completed on time, fully compliant, and effective in preventing recurrence.
Ensure timely product release in accordance with production planning and delivery schedules, with effective utilization of SAP for release processes.
Review and improve QA systems, SOPs, and quality-related procedures to maintain compliance and support continuous improvement.
Drive Quality Risk Management (QRM) activities to ensure QMS compliance with regulatory requirements and industry best practices.
Support Regulatory Affairs with product registration (local and overseas) by compiling and providing relevant QA documentation.
Monitor and ensure that products are manufactured, stored, and distributed in accordance with GMP and regulatory requirements.
Ensure customer satisfaction with regards to product quality through implementation of corrective and preventive actions to improve product quality.
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