Quality Control Chemist

REGTECH INSIGHT PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading regulatory technology firm in Singapore seeks a QC Engineer to ensure compliance with global validation standards in a regulated GMP environment. The ideal candidate will possess 3–10 years of experience in Computer System Validation for analytical instruments. Responsibilities include leading validation activities, developing deliverables, and ensuring data integrity compliance. Opportunities for growth and contribution to continuous improvement are available.

Qualifications

• 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.

Responsibilities

• Lead CSV activities for analytical equipment or instruments.
• Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ.
• Ensure compliance with 21 CFR Part 11 and data integrity controls.

Skills

Computer System Validation (CSV)

cGMP

GAMP 5

documentation skills

troubleshooting skills

cross-functional collaboration

Education

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

Tools

Kneat

HPLC

GC

UV

LIMS

Empower

Job description

Role Overview

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.