This role involves ensuring clinical supplies are stored and distributed according to regulatory standards, maintaining compliance with quality systems, and conducting quality inspections. Responsibilities also include managing non-conformances and participating in departmental initiatives for quality improvement.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Warehouse
Job Description
Position Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services approved procedures and policies, cGMP, cGDP, and regulatory requirements.
Maintain the FCS Singapore Quality System in compliance with Fisher Clinical Services approved procedure and policies, cGMP, cGDP, and regulatory requirements.
Essential Duties and Responsibility:
- Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
- Provide guidance and advice to clients, suppliers and internal associates on quality matters.
- Perform auxiliary/ incoming inspections as per established procedures and cGMP standards
- In-process inspection responsibilities for production and label printing jobs
- Assist in management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
- Assist in quality compliance of controlled temperature shipments
- Approval of components and material specifications
- Responsible for the release of client/Fisher supplied materials
- Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
- Perform ad-hoc duties as requested by direct superior or line management
Minimum Requirements/Qualifications:
- Min. GCE O Level, SPM, NTC 3 or equivalent qualification
- At least 2 years’ experience in pharmaceutical/ medical/ healthcare settings
- Added advantage with cGMP working experience in the field of quality assurance/ quality control related activities
- Meticulous and detailed oriented
- Able to work in cold room and freezer environment
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Top Skills:
Quality Assurance
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