Salary: up to $3500
Working Days & Hours: Mon-Fri Office Hours
Lab Maintenance (System)
• A Subject Matter Expect (SME) of Microbiological/ Sterility Assurance tests.
• Lead and conduct method trainings to new lab personnel.
• Initiate and investigate GEMS event via Trackwise system and Laboratory Investigation Report (LIR).
• Participate in cross functional root cause analysis (RCA) during investigation.
• Perform review and approval on QC test results.
• Involve in audit preparation and ready to present during an inspection.
• Lead a Lean Green Belt (LGB) project when tasked.
• Lead a cost saving project when tasked.
• Participate and perform method validation/ study when tasked.
• Required to write different types of reports, such as trend report, technical or study report, memo,
validation report, investigation report etc.
• Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.
• Perform data compilation and trending on a monthly basis when required.
• Have a good understanding on 5S methodology and able to transform an area using 5S methodology;
• Vigilantly report/ highlight issues or unsafe act.
• Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.
Lab Maintenance (Instrument)
• Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object
(TCO), Biosafety Cabinet (BSC), etc.
• Responsible for ownership of sophisticated lab equipment and conduct training to respective lab
• Arrange equipment calibration with external vendor.
• Manage and maintain service contract with vendor when required.
• Perform peer review on equipment logbook.
• Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT),
Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate
• Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw
materials, investigational non-routine samples.
• Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.
• Perform aliquoting on Process and Non-Protein samples on a daily basis.
• Support Lab Services team on replenishment of inventory from warehouse on a weekly basis.
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s
Code of Conduct.
• Any other duties as assigned by supervisor
Job Requirements: Min Diploma / Degree in any Science aspect
Interested canddiates, please submit your resume to: [ Email address blocked ]
Ally Audrey Lok Xin Woon
Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R21102307
[ Email address blocked ]
- Verifying that product quality attributes
- Implementing changes to the quality system
- Ensure sound quality decisions are made
- Identify ways to provide quality control and quality assurance through the inspection and reporting process
- Ensure accuracy and completeness of quality review
- Adhere to the laboratory's quality control policies
- Adhere to all requirements of established quality systems
- Ensure awareness of quality issues on the project
- Perform quality check on manufacturing shop drawings
- Provide quality inspections on all related items
- Develop and implement quality systems and procedures
- Perform quality check on metal fabrication documents
- Assist in quality audits and perform corrective actions
- Maintain high standards for quality work and responsiveness
- Assist in coordinating external vendor and subcontractor quality audits
- Take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency
- Take the initiative to improve the quality of operations and to improve and maintain a quality culture
- Conducting and forming corrective action plans for internal quality audits, customer quality audits and regulatory inspections
- Assist quality, engineering and production personnel with investigations of part defects or any quality related issues
- Review quality data and make proposals for continuous improvement
- Product Quality Assurance
- Corrective And Preventive Actions