Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Perform day-to-day Quality Assurance activities to ensure compliance with GMP, company procedures, regulatory requirements, and the Quality Management System.
Review and approve batch manufacturing records, packaging records, specifications, procedures, protocols, and other GMP-related documents.
Support batch release and product disposition activities by ensuring all required documentation and quality requirements are satisfactorily completed.
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Conduct regular inspections on-site to monitor construction activities and ensure compliance with project specifications, drawings, and quality standards.
Identify and report any non-conformities or workmanship issues, and follow up on corrective actions.
Prepare and submit daily site progress reports, including work status, manpower, materials used, and site observations.
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Check email daily to receive inspection documents.
Attend to inspections on time and communicate with supplier in a professional way.
Perform the inspection of the merchandise according with company procedures. Supervise the stuffing of the containers according with company procedures.
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Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.
Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material. Document non-conforming materials and initiate appropriate corrective actions.
Collaborate with supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.
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Check email daily to receive inspection documents.
Attend to inspections on time and communicate with supplier in a professional way.
Perform the inspection of the merchandise according with company procedures. Supervise the stuffing of the containers according with company procedures.
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Check email daily to receive inspection documents.
Attend to inspections on time and communicate with supplier in a professional way.
Perform the inspection of the merchandise according with company procedures. Supervise the stuffing of the containers according with company procedures.
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Global QMS Management: Driving the GSQ WW QMS document creation, approval and maintenance. Developing and deploying robust Global Supplier Quality processes and procedures. Document control, maintenance and continual improvement of Supplier Quality processes.
Audit Program Oversight: Coordinator for Global audits and maintaining and implementing the assignment of auditors from the global auditor register. Management and reporting of risk-based Supplier Audit program. Performing Supplier Qualification audits to assess quality systems, technical capability and process capability.
Auditor Roster Management: Maintain the global qualified auditor register, ensuring qualified auditors are appropriately assigned to audit engagements.
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