QC Analytical Scientist — Method Validation & GMP

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Coalesce Management Consulting seeks a QC Analytical Scientist to perform laboratory testing and support analytical method validation within a GMP-regulated pharmaceutical or biopharmaceutical environment in Singapore. The role emphasizes rigorous data review, accurate documentation, and strict adherence to GMP standards.

The successful candidate will execute routine and non-routine analyses on raw materials, in-process samples, drug substances/products, and stability materials, while

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Science, Biotechnology or related field.
• Hands-on analytical laboratory experience in GMP-regulated environments.
• Experience supporting analytical method validation activities.
• Strong understanding of GMP, data integrity and documentation lifecycle.
• Able to write clear, compliant technical reports and SOPs.

Responsibilities

• Perform routine and non-routine analytical testing of materials and products.
• Execute analyses per approved methods, specifications, SOPs and GMP requirements.
• Support method validation lifecycle including protocol prep, execution, review and reporting.
• Evaluate validation characteristics (accuracy, precision, specificity, etc.).
• Review data, chromatograms, and lab records for accuracy and compliance.
• Document investigations into deviations, OOS/OOT results and CAPA.
• Prepare GMP documentation and maintain instrument qualification records.
• Operate and troubleshoot instruments (HPLC/UPLC/GC/UV-Vis) and related equipment.
• Collaborate with QC, Analytical Development, Process Development and QA.

Skills

Lab testing

Data review

Method validation

GMP practices

Technical writing

Education

Bachelor's degree in Chemistry

Tools

HPLC

UPLC

GC

UV-Vis

Job description

Coalesce Management Consulting seeks a QC Analytical Scientist to perform laboratory testing and support analytical method validation within a GMP-regulated pharmaceutical or biopharmaceutical environment in Singapore. The role emphasizes rigorous data review, accurate documentation, and strict adherence to GMP standards.

The successful candidate will execute routine and non-routine analyses on raw materials, in-process samples, drug substances/products, and stability materials, while