Job Description

Description

• Lead and conduct method trainings to new lab personnel.
• Initiate and investigate deviation via Trackwise system and Laboratory Investigation (LI).Initiate and manage the change control task in Trackwise system.
• 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 / equipment qualification 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.
• Manage the inventory level and purchasing of consumable used for testing.
• 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.
• Perform equipment relocation when task Perform equipment qualification, prepare the documents required for qualification as per global procedure.
• Perform EMPQ on the new room qualification.
• Work with vendor to schedule for vendor IOPQ if required.
• Arrange equipment calibration with external vendor.
• Perform microbiological testing, namely environment monitoring (EM), and plate reading/ plate verification.
• 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.

Requirements * Min Bachelor\'s Degree in Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent, preferably with 1-2 years of experience in cGMP Pharmaceutical, Biopharmaceutical, or related manufacturing environment and/ or related laboratory experience.

• Experience in performing QC testing.
• Preferably Experience in conducting microbiological study, investigation and cost saving projects etc.

Interested candidates please send a copy of your resume to

Lynn Ho R23114223

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Others
Production / Manufacturing
Public Sector / Government & Statutory Boards
Semiconductor / Electronics / Engineering

Specialization

Chemist / Research Scientist
Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs

Location

Central, North, East, West

Employment Type

Part-time
Contract / Temp
Permanent

Salary

Negotiable

If you meet the requirements of this role, please email a detailed resume in Word document to Lynn Ho Lin Ying (Outsourcing Team).

Interested candidates please send a copy of your resume to

Lynn Ho R23114223

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

Recruit Express