QC Scientist - Testing

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a Quality Control/QA professional with experience in IPC, DS/DP testing, HPLC, GC, CE-SDS and cell-based potency to join our biopharma team in Singapore.

You will maintain detailed inspection records, prepare management reports, analyze defects, identify root causes for deviations and drive CAPAs, ensuring products comply with internal standards, cgmp, and regulatory guidelines (FDA/EMA/ICH/WHO).

Qualifications

• Bachelor's Degree in biotech or biopharmacy.
• 3 years of relevant working experience.
• A good understanding of the overall view of drug development process.
• A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
• Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.
• Comprehensive knowledge in IND/IMPD, NDA and ANDA filing

Responsibilities

• Maintain detailed records of inspections, test results, and deviations.
• Prepare reports summarizing findings for management.
• Analyze defects, identify root causes for process deviations, and work with production teams to implement corrective and preventive actions.
• Ensure products conform to internal standards, industry regulations, and safety requirements.
• Develop and update quality control procedures, standards, and protocol

Skills

IPC testing

DS/DP testing

HPLC

GC operations

CE-SDS

cIEF

ELISA

Potency testing

TOC testing

Documentation

Education

Bachelor's degree in biotech or biopharmacy

Tools

Karl Fischer Titrator

TOC analyzer

UV-Vis spectrophotometer

Job description

Job Summary

Experiences in IPC, finished products (DS/DP) testing.

Experience in HPLC & GC operations & troubleshooting, CE-SDS, cIEF, cell based potency, ELISA based qualification, Karl Fischer Titrator, Total Organic Carbon (TOC) testing, Solo VPE/UV-Vis Spectrophotometer

Keep detailed records of inspections, test results, and deviations. Prepare reports summarizing findings for management.

Analyze defects, identify root causes for process deviations, and work with production teams to implement corrective and preventive actions.

Ensure products conform to internal standards, industry regulations, and safety requirements.

Develop and update quality control procedures, standards, and protocol

Requirements

• Bachelors Degree in biotech or biopharmacy
• 3 Years of relevant working experience
• A good understanding of the overall view of drug development process.
• A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
• Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.
• Comprehensive knowledge in IND/IMPD, NDA and ANDA filing