Quality Assurance Manager: Cord Blood & Regulatory Audits

MTC Consulting Pte. Ltd.; Singapore; Vor Ort; SGD 78.000 - 100.000; Vollzeit

Zusammenfassung

MTC Consulting Pte. Ltd. seeks a QA Manager to develop and oversee quality assurance for the cord blood banking process, ensuring compliance with accredited standards.

The role involves leading audits, managing inspections by AABB, FACT, CAP, and HSCA, and driving corrective actions to maintain audit-ready records. The ideal candidate will have at least 3 years in QA within a regulated healthcare laboratory or biobanking environment, with ASQ QA certification preferred and strong communication

Qualifikationen

• Certification in Quality Assurance preferred (ASQ).
• Minimum 3 years of QA experience in regulated environments, cord blood banking or healthcare laboratory setting.
• In-depth knowledge of accreditation requirements (AABB, FACT, CAP, HSCA) and GxP standards (GCP, GLP, GDP).
• Strong analytical, problem-solving, and communication skills.

Aufgaben

• Develop, implement, and monitor quality assurance policies and procedures for the cord blood banking process.
• Lead internal and external audits, ensuring regulatory compliance and industry best practices.
• Prepare for and manage inspections from accrediting bodies such as AABB, FACT, CAP, and HSCA (MOH).
• Monitor and report on quality indicators, ensuring timely corrective actions when necessary.
• Ensure that the laboratory team follows all SOPs and complies with accreditation standards.
• Conduct training for laboratory and clinical staff on quality management systems, SOPs, regulatory requirements, and GxP principles (GCP, GLP, GDP).
• Maintain accurate records of all quality-related activities, audit readiness at all times.
• Collaborate with other departments to address non-conformances and initiate corrective and preventive actions.

Kenntnisse

Analytical thinking

Problem-solving

Communication skills

Auditing experience

Ausbildung

ASQ Certified Quality Auditor

Jobbeschreibung

MTC Consulting Pte. Ltd. seeks a QA Manager to develop and oversee quality assurance for the cord blood banking process, ensuring compliance with accredited standards.

The role involves leading audits, managing inspections by AABB, FACT, CAP, and HSCA, and driving corrective actions to maintain audit-ready records. The ideal candidate will have at least 3 years in QA within a regulated healthcare laboratory or biobanking environment, with ASQ QA certification preferred and strong communication