- 50 SCIENCE PARK ROAD West Region (Singapore) Singapore
Working Location
Job Description
Responsibilities
Company Overview
Vela Diagnostics provides innovative diagnostic workflows for disease screening, diagnosis, and monitoring. Serving hospitals, labs, and research, they optimize processes and support medical decisions with standardized test menus and expert professionals.
Job Summary
This position is part of a driven team that performs In-Vitro Diagnostics Assay production via various molecular manufacturing techniques. Activities conducted would be required to comply with industrial and regulatory requirements. The successful candidate will be based in Singapore and reports to the manufacturing team.
Responsibilities
• Bulk Formulation at Microliter (uL) and Milliliter (ml) levels in a laboratory environment
• Tubes / Bottles / Plates dispensing via automated and manual processes
• Printing, Labeling, Kit Assembling and Packing of products.
2. Ensure daily/monthly production targets are achieved with products manufactured according to established SOPs equipped with knowledge of upstream and downstream processes.
3. Ensure Manufacturing Yield/Defect Rate targets are achieved via proper handling of goods at the raw materials, semi-finished goods and finished goods level.
4. Ensure batch records are maintained according to ISO standards.
5. Ensure daily maintenance work in Manufacturing floor, including waste disposal, equipment maintenance, and cleanliness maintenance are completed.
6. Participate and collaborate with quality in root cause analysisactivity on non-conforming incident. Recommend and implement corrective and preventive action.
7. Involved in quality and safety risk assessment, audits, biosafety, and emergency response.
8. Inventory control of reagents and supplies via ERP and non-ERP systems.
9. Author deviation, reports, and documentations where necessary.
10. Participate in method transfer and process validation.
11. Collaborate with cross-functional teams (e.g. Quality, PT, R&D, Supply Chain and Quality Assurance) on product transfer and process improvement projects.
12. Author and improve MWI and MFM.
13. Other duties as assigned.
Preferred competencies and qualifications
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