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QA/PV Executive - PHARMA job in Singapore at Recruit Express Pte Ltd

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QA/PV Executive - PHARMA at Recruit Express Pte Ltd

QA/PV Executive - PHARMA

Recruit Express Pte Ltd Singapore Permanent
2,800 SGD - 3,500 SGD/Month
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Salary: up to $3500
Working Days & Hours: Mon-Fri Office Hours
Location: Novena 
Job Description:
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
personnel.
• Arrange equipment calibration with external vendor.
• Manage and maintain service contract with vendor when required.
• Perform peer review on equipment logbook.
Routine Testing
• Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT),
Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate
reading.
• 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.
General Responsibilities
• 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

Recommended Skills

  • Product Quality Assurance
  • Auditing
  • Testing
  • Corrective And Preventive Actions
  • Warehousing
  • Operations

EA License No.

99C4599

EA Personal Registration No.

R21102307
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