QC Lab Systems Specialist II - GMP, LIMS/CDS Expert

ThermoFisher Scientific; Singapore; On-site; SGD 60,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific in Singapore invites an Engineer/Scientist II, QC to perform testing and data analysis in a GMP environment. You will handle raw materials, in-process samples and finished products using state-of-the-art analytical equipment to ensure product quality.

Prepare qualification protocols and reports, participate in continuous improvement, and collaborate with lab personnel, IT and vendors to maintain calibrated systems and meet regulatory expectations.

Qualifications

• Bachelor's degree in a relevant scientific field with 3–5 years of experience
• Strong knowledge of GMP regulations and quality systems requirements
• Proficiency in analytical systems including LIMS, CDS, HPLC, GC, UV, IR
• Knowledge of regulatory standards (ISO, FDA, USP, EP)
• Ability to work independently and meet critical timelines
• Excellent written and verbal communication in English
• Experience with laboratory automation systems preferred

Responsibilities

• Lead and deploy lab system projects as site SME (CDS/LIMS) to meet timelines and deliverables
• Lead, perform and support qualification of new equipment and lab systems according to regulatory expectations
• Prepare technical documentation including qualification protocols and reports
• Collaborate with stakeholders to ensure QC lab facilities, utilities, systems and equipment are maintained and calibrated
• Ensure equipment maintenance and calibration are scheduled timely and compliant
• Support lab investigations related to lab systems and equipment as SME
• Coach colleagues with knowledge of lab systems and equipment
• Participate in Practical Process Improvement initiatives (PPI) and continuous improvement
• Promote a Quality Culture and 5S mindset in QC
• Ensure cGMP compliance across the business
• Contribute to site audits for regulatory readiness

Skills

English communication

Attention to detail

Time management

Independent work

Team collaboration

Education

Bachelor's Degree in Science

Tools

LIMS

CDS

HPLC

GC

UV

IR

Job description

Thermo Fisher Scientific in Singapore invites an Engineer/Scientist II, QC to perform testing and data analysis in a GMP environment. You will handle raw materials, in-process samples and finished products using state-of-the-art analytical equipment to ensure product quality.

Prepare qualification protocols and reports, participate in continuous improvement, and collaborate with lab personnel, IT and vendors to maintain calibrated systems and meet regulatory expectations.