Description
- Responsible for spearheading, implementing and maintaining the Company’s Quality Management System in compliance with:
- 1) regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to the company’s services and products
- 2) accreditation and certification standards; AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the CGL’s services/products
- 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
- Training and distribution of Quality practices within Company and regional teams when required.
- 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 departments are up to date with annual document reviews.
- Work with regional offices on quality matters.
- 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
- Setting up of Quality Management Practices and assist in risk assessment for new services or entities assigned
Requirements
- Degree with 3 years in Quality Management, preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry,
- With 2 years in a managerial position.
- Led organization in regulatory assessments and accreditation preparation and audits
- Process improvement knowledge and experience
- Ability to handle tight deadlines and irregular situations
- Good change agent, ability to positively influence others to facilitate a quality and change mindset
- Good communication skills
- Candidates with more experience will be considered for a Senior role
Interested applicants, please send your resume to: [email protected]
EA Personnel R1109773
Agency no 07C3676
