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Quality Associate

2 weeks ago

Singapore Thermo Fisher Scientific Inc. Full time

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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