Job Description

Description

Lab Maintenance (System)

\xc2\xb7 A Subject Matter Expect (SME) of Microbiological/ Sterility Assurance tests.

\xc2\xb7 Lead and conduct method trainings to new lab personnel.

\xc2\xb7 Initiate and investigate deviation via Trackwise system and Laboratory Investigation (LI).

\xc2\xb7 Initiate and manage the change control task in Trackwise system.

\xc2\xb7 Participate in cross functional root cause analysis (RCA) during investigation.

\xc2\xb7 Perform review and approval on QC test results.

\xc2\xb7 Involve in audit preparation and ready to present during an inspection.

\xc2\xb7 Lead a Lean Green Belt (LGB) project when tasked.

\xc2\xb7 Lead a cost saving project when tasked.

\xc2\xb7 Participate and perform method validation/ study / equipment qualification when tasked.

\xc2\xb7 Required to write different types of reports, such as trend report, technical or study report, memo, validation report, investigation report etc.

\xc2\xb7 Revise Standard Operating Procedures (SOP) and EHS Risk Assessment.

\xc2\xb7 Perform data compilation and trending on a monthly basis when required.

\xc2\xb7 Manage the inventory level and purchasing of consumable used for testing.

\xc2\xb7 Have a good understanding on 5S methodology and able to transform an area using 5S methodology.

\xc2\xb7 Vigilantly report/ highlight issues or unsafe act.

\xc2\xb7 Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.

Equipment and Room qualification

\xc2\xb7 Perform equipment relocation when task

\xc2\xb7 Perform equipment qualification, prepare the documents required for qualification as per global procedure.

\xc2\xb7 Perform EMPQ on the new room qualification.

\xc2\xb7 Work with vendor to schedule for vendor IOPQ if required.

\xc2\xb7 Arrange equipment calibration with external vendor.

Routine Testing

\xc2\xb7 Perform microbiological testing, namely environment monitoring (EM), and plate reading/ plate verification.

\xc2\xb7 Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw materials, investigational non-routine samples.

\xc2\xb7 Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.

\xc2\xb7 Perform aliquoting on Process and Non-Protein samples on a daily basis.

\xc2\xb7 Support Lab Services team on replenishment of inventory from warehouse on a weekly basis.

List of job requirements. * \xc2\xb7 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.

• \xc2\xb7 Diploma in Microbiology, Biological Sciences, Life Sciences, Biotechnology with minimal 6 years of related cGMP laboratory experience.
• \xc2\xb7 Experience in performing QC testing.
• \xc2\xb7 Preferably Experience in conducting microbiological study, investigation and cost saving projects etc.

If you are interested in the position, do kindly drop your most updated resume to (Attn: Microbiologist)

Thank You.

Lynn Ho

R23114223

Recruiter\'s Ref Code: #HHO

EA License: 99C4599

Industry

Education & Training
Healthcare / Pharmaceutical / Life Science / Medical Device
Others
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

Contract / Temp
Permanent

Salary

S$4,001 - S$6,000 / mth

If you meet the requirements of this role, please email a detailed resume in Word document to Lynn Ho Lin Ying.
CEI Registration No.: R23114223

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

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