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Senior Quality Assurance Manager
2 weeks ago
We are seeking a highly skilled Quality Manager to lead and manage the Quality Assurance function in our Analytical Testing Laboratory. The ideal candidate will have extensive experience in handling critical audits, including USFDA, CAPA, GLP, WHO, NABL, and internal audits. This role demands expertise in maintaining robust quality systems, managing audits, and driving corrective and preventive actions (CAPA) to ensure the lab operates to the highest quality standards.
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) to comply with regulatory requirements (USFDA, WHO, NABL, GLP) and industry standards (ISO, ICH).
- Oversee the preparation and management of documentation including standard operating procedures (SOPs), batch records, test methods, and analytical reports to ensure compliance with regulatory standards.
- Implement risk management strategies to identify, assess, and mitigate quality-related risks within the testing laboratory.
Audit and Compliance Oversight:
- Lead and manage USFDA, WHO, NABL, GLP, and other regulatory audits, ensuring full preparedness and compliance.
- Coordinate and conduct internal audits to assess the effectiveness of the laboratory's quality system, identifying areas for improvement and ensuring alignment with company policies and regulatory standards.
- Ensure timely and effective resolution of audit findings by developing and executing Corrective and Preventive Actions (CAPA) in accordance with regulatory guidelines and company practices.
- Serve as the primary point of contact during external regulatory audits, inspections, and accreditation assessments.
- Collaborate with regulatory bodies and external stakeholders to ensure continuous improvement in quality and compliance.
CAPA Management:
- Lead the CAPA (Corrective and Preventive Action) process, ensuring thorough investigation and documentation of non-conformances, root cause analysis, and implementation of effective corrective and preventive actions.
- Track CAPA effectiveness and ensure corrective actions are sustainably integrated into the laboratory processes to prevent recurrence of issues.
Team Leadership & Training:
- Supervise, mentor, and train laboratory personnel on quality standards, testing protocols, regulatory compliance, and internal procedures.
- Conduct regular training sessions to ensure team competency in GMP, GLP, and audit readiness.
- Promote a culture of continuous quality improvement across the lab, encouraging proactive problem-solving and adherence to quality systems.
