Quality Control Chemist

JEET ANALYTICS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading analytics firm in Singapore is seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments. You will lead CSV activities, develop validation deliverables, and ensure compliance with global validation standards. The ideal candidate has a Bachelor's degree in a relevant field and 3–10 years of experience in pharmaceutical/biotech QC labs, with strong knowledge of cGMP and data integrity controls.

Qualifications

• 3–10 years’ experience in analytical instrument/equipment CSV within pharmaceutical/biotech QC labs.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
• Hands-on experience with microbiology analytical equipment is an advantage.

Responsibilities

• Lead CSV activities for analytical equipment or instruments and lab computerized systems.
• Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ.
• Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles.

Skills

Computer System Validation (CSV)

Data integrity

cGMP

Documentation skills

Troubleshooting skills

Education

Bachelor’s degree in chemistry, Life Sciences, Engineering, or related discipline

Tools

Kneat

HPLC

GC

UV

LIMS

Empower

Job description

We are seeking a QC Engineer with strong experience in Computer System Validation (CSV) for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.

Key Responsibilities

• Lead CSV activities for analytical equipment or instruments and lab computerized systems (e.g., HPLC, GC, UV, LIMS, Empower).
• Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ, RTM, and summary reports.
• Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity controls.
• Evaluate and validate audit trails, security settings, and user access controls.
• Support integration between instrument, PC, network, and enterprise systems.
• Draft, review, and maintain SOPs, validation documentation, and audit readiness materials.
• Contribute to lifecycle management of systems including periodic reviews, upgrades, and change control.
• Collaborate with QA, QC, and IT to support inspection readiness and continuous improvement.

Requirements

• Bachelor’s degree in chemistry, Life Sciences, Engineering, or related discipline.
• 3–10 years’ experience in analytical instrument/equipment CSV within pharmaceutical/biotech QC labs.
• Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11.
• Hands-on experience with microbiology analytical equipment is an advantage.
• Familiarity with electronic validation tools (e.g., Kneat) is preferred.
• Strong documentation, troubleshooting, and cross-functional collaboration skills.