*NEW* Micro Lab Analyst / Microbiologist (Full-time / Immediate) #HJG

Lab Maintenance (System)

• Serve as a Subject Matter Expert (SME) for microbiological and sterility assurance tests

• Lead and conduct method training for new lab personnel

• Initiate and investigate deviations using the Trackwise system and Laboratory Investigations (LI)

• Manage change control tasks in Trackwise and participate in root cause analysis (RCA) investigations

• Review and approve QC test results

• Assist in audit preparation and present during inspections

• Lead Lean Green Belt (LGB) and cost-saving projects when tasked

• Participate in method validation, studies, and equipment qualification activities

• Write reports including trend reports, technical reports, investigation reports, and validation reports

• Revise Standard Operating Procedures (SOPs) and perform Environmental, Health & Safety (EHS) Risk Assessments

• Compile and trend data on a monthly basis

• Manage inventory and purchase consumables for testing

• Apply 5S methodology to improve lab areas

• Ensure good housekeeping and inventory management to prevent testing delays

Equipment and Room Qualification

• Perform equipment relocation tasks when required

• Conduct equipment qualifications, ensuring all documentation complies with global procedures

• Perform Environmental Monitoring for Pharmaceutical Quality (EMPQ) for new room qualifications

• Coordinate with vendors for equipment qualification (IOPQ) and arrange calibration

Routine Testing

• Perform microbiological testing, including environmental monitoring (EM), plate reading, and plate verification

• Conduct microbiological tests on critical utilities, raw materials, in-process/ Bulk Drug Substances (BDS), and investigational samples

• Perform sterilization cycles using qualified autoclaves and depyrogenation cycles

• Support aliquoting of Process and Non-Protein samples on a daily basis

• Replenish lab inventory as needed

General Responsibilities

• Comply with all applicable Environmental, Health, and Safety (EHS) regulations

• Uphold Takeda's Code of Conduct in all interactions

• Perform other duties as assigned by the supervisor

Job Requirements:

• Experience in QC testing and performing microbiological investigations is preferred

• Experience in conducting microbiological studies, investigations, and cost-saving projects is a plus

• Proficient in cGMP quality systems and industry guidelines (e.g., Trackwise, Change Control, and documentation systems)

• Strong analytical and problem-solving skills

• Ability to train and communicate effectively with team members

• Knowledge of safety principles, practices, and procedures

• Proficient with Microsoft Office applications

If you are interested in this position, do kindly drop your most updated resume to [email protected] and [email protected] (Attn: Micro Lab Analyst / Microbiologist)
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599