QC Systems Engineer

Advanced Manufacturing Tech Solutions (AMTSOL)

Job Location:

Singapore - Singapore

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Advanced Manufacturing Tech Solutions (AMTSOL) -

A leader in Life Science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business.

Role: System Owner Delegate QC Systems (Lab Equipment CSV)

Location: Singapore

The role will act as a key liaison between QC IT Automation and Validation teams ensuring laboratory computerized systems remain compliant validated and inspection-ready in accordance with global regulatory requirements

Key Responsibilities

Act as System Owner Delegate for QC laboratory computerized systems and analytical equipment.
Ensure systems remain compliant with GxP 21 CFR Part 11 EU Annex 11 and Data Integrity requirements.
Support CSV lifecycle activities including URS risk assessments validation planning IQ/OQ/PQ oversight and change control.
Review and approve validation documentation in alignment with corporate and regulatory standards.
Manage system updates patches configuration changes and periodic reviews.
Support deviation investigations CAPAs and audit/inspection readiness activities.
Coordinate with vendors IT teams and cross-functional stakeholders for system enhancements and troubleshooting.
Ensure backup disaster recovery access management and data integrity controls are maintained.

Required Experience & Skills

5 years of experience in Pharmaceutical / Life Sciences Manufacturing environment.
Strong hands-on experience in Computerized System Validation (CSV) for laboratory systems.
Experience supporting QC Lab systems such as:

LIMS
CDS (e.g. Empower OpenLab)
ELN
Analytical instruments and standalone lab equipment systems

Good understanding of:

GAMP 5 guidelines
Data Integrity principles
Change Management & Risk Management

Experience supporting regulatory audits (FDA EMA MHRA etc.).
Strong documentation stakeholder management and problem-solving skills

Advanced Manufacturing Tech Solutions (AMTSOL) - A leader in Life Science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business. Role: System Owner Delegate QC Systems (Lab Equipment CSV) Location: Singapore The role wil...