Senior Scientist - Electronic System

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a qualified professional to oversee electronic system applications including LIMS, SAP, Maximo and Empower, acting as SME and liaising with global functions. The role involves audits, QC user training, and ensuring cGMP/data integrity compliance within EHS standards.

The candidate should hold a bachelor degree or higher in pharma/chemistry or related fields, with 6–12 years in biotech/biopharma and a strong grasp of FDA/EMA/ICH regulations and drug

Qualifications

• Bachelor degree or above in pharmacy, chemistry, biochemistry, analytics or related discipline.
• 6-12 years experience in biotech or biopharma.
• Deep understanding of FDA, EMA, ICH regulations.
• Understanding of drug development process.
• Strong knowledge of cGMP compliance and data integrity.

Responsibilities

• Responsible for electronic system application, including LIMS, Cispro, LES, SAP, Maximo and Empower.
• Serve as SME for electronic system and collaborate with global functions.
• Serve as SME during audit.
• Training QC users, external functions.
• Troubleshooting when necessary.
• Ensure activities in QC team comply with cGMP, data integrity and EHS.

Skills

Regulatory understanding

cGMP knowledge

Quality mindset

Audit support

Education

Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or related discipline

Job description

Responsibilities:

• Responsible for electronic system application, including but not limit to LIMS, Cispro, LES, SAP, Maximo and Empower.




• Serve as SME for electronic system and collaborate with global functions.




• Serve as SME during audit




• Performing training to QC users, external functions




• Perform troubleshooting when necessary




• Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.

Requirements:

• Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline




• With6 - 12 years in biotech or biopharma




• Deep understanding of FDA, EMA, ICH related regulations




• 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