Description
- Responsible for spearheading, implementing and maintaining the Company’s Quality Management System
- Ensure requirements for AABB, FACT as well as MOH license guidelines are implemented and maintained
- Report performance of the quality activities minimally on a quarterly basis and management review annually.
- Responsible for interfacing with regulators and external quality auditors.
- Monitor and review quality indicators and quality related reports.
- Provide guidance to departments in the review and refinement of current practices and protocols/processes, as well as risk assessment.
- Lead / Facilitate other departments in the root cause analysis of non-conformances to put in place effective corrective actions.
- Facilitate proper process control relevant to services and products that affects safety, identity, purity and potency.
- Initiate process improvement practices and benchmarking to industry practices across departments to raise standards of operational excellence and service delivery
- Act as company’s management representative in compliance assessments and coordinate with regulatory or accreditation bodies as and when required.
- Oversee the maintenance of document control centre and system for proper and updated records of quality documents.
- Assist and lead in root cause analysis, work process improvements and problem solving together with departments.
- Lead the monitoring of quality objectives/indicators across departments to ensure quality of products and services are maintained according to SOP and regulatory/accreditation requirements.
- Review processing records and other reports as required by applicable regulatory and/or accreditation standards.
- Drive yearly internal audits for audit readiness and interdepartmental coordination.
- Ensure quality training for new and existing employees is performed and to ensure competencies of the quality department are up to date.
- Support with supplier/vendor qualifications with participating departments.
- Coordinate and review on a periodic basis, operational and quality risk assessment, including workplace safety.
- Review, perform and lead gap analysis of new/revised standards published by regulatory and accreditation bodies to ensure departmental SOPs are in compliance
Job Requirement:
- Min. Degree 5 years of working experience in Quality Management, preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry,
- Min 2 years in a managerial position.
- Led organization in regulatory assessments and accreditation preparation and audits
- Ability to handle tight deadlines and irregular situations
- Good change agent, ability to positively influence others to facilitate a quality and change mindset
For interested applicants, please send your updated resume to: [email protected] All candidates’ information will be treated with the strictest confidence
Melissa Zhang Zhiqi (Mezzo)
R2197564
Recruit Express Pte Ltd
99C4599
