Position Summary
Responsible for developing, implementing, and overseeing the quality assurance processes and systems to uphold the highest standards of product quality and compliance.
Responsibilities
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Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with relevant regulations and standards
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Conduct regular assessments to ensure the effectiveness and continuous improvement of the QMS
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Stay abreast of international pharmaceutical & device regulations and standards, ensuring the company's compliance with regulatory requirements
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Collaborate with regulatory affairs teams to obtain and maintain product registrations and certifications
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Establish and oversee quality control processes for incoming goods
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Implement auditing protocols to ensure the quality and consistency of pharmaceutical and medical devices
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Develop and maintain strong relationships with suppliers & vendors, conducting regular audits and assessments to ensure supplier/vendors compliance with quality standards
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Collaborate with procurement teams to qualify and monitor suppliers/vendors
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Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize processes
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Lead investigations and corrective/preventive action plans in response to quality issues
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Establish and monitor KPIs related to product quality, compliance, and operational efficiency
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Regularly report on KPI performance and implement corrective actions as needed
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Provide leadership and guidance to the Quality Assurance team
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Develop and deliver training programs to enhance the skills and knowledge of QA staff and other related staffs