Micro Lab Analyst

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A healthcare recruitment agency in Singapore is looking for a Lab Maintenance (System) expert to lead microbiological testing and training of lab personnel. The role involves managing QC test results, ensuring compliance with safety regulations, and conducting performance reviews during audits. Candidates should be proficient in cGMP quality systems and possess strong analytical skills. Interested applicants are encouraged to send their resumes to the provided email addresses.

Qualifications

• Preferred experience in QC testing and microbiological investigations.
• Knowledge of cGMP quality systems and industry guidelines.
• Ability to train and communicate effectively with team members.

Responsibilities

• Serve as a Subject Matter Expert for microbiological tests.
• Lead training for new lab personnel.
• Perform routine microbiological testing and environmental monitoring.
• Assist in audit preparation and inspections.

Skills

Analytical skills

Problem-solving skills

Communication skills

Team training

Tools

Trackwise

Microsoft Office

Job description

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 [e-mail] and [e-mail] (Attn: Micro Lab Analyst / Microbiologist)
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599