Quality Assurance Manager
4 days ago
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO/IEC 17025 or other applicable standards.
- Oversee quality audits, corrective/preventive actions (CAPA), and root cause analysis.
- Monitor laboratory and operational processes to ensure adherence to quality standards.
- Manage and maintain the Laboratory Information Management System (LIMS) to ensure data accuracy and accessibility.
- Ensure timely compliance with regulatory requirements, including the preparation, submission, and renewal of accreditations and government permits.
- Coordinate with external auditors, accrediting bodies, and regulatory agencies for inspections and renewals.
- Provide training to staff on quality protocols, LIMS use, compliance requirements, and regulatory updates.
- Review and approve quality-related documents, reports, and SOPs.
- Collaborate with operations, technical, and administrative teams to resolve quality issues and implement improvements.
Qualifications:
- Bachelor's degree in Chemistry, Microbiology, Engineering, or related field.
- At least 5 years of experience in Quality Assurance, preferably in a laboratory or testing environment.
- Hands-on experience with Laboratory Information Management Systems (LIMS).
- Knowledge of ISO/IEC 17025, regulatory compliance processes, and accreditation management.
- Strong analytical, communication, and leadership skills.
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