QC Analyst QC Systems Specialist

Advanced Manufacturing Tech Solutions (AMTSOL)

Job Location:

Singapore - Singapore

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

We are looking for experienced QC Analysts / QC Systems Specialists to support laboratory operations QC systems management and data integrity compliance. The ideal candidate will bring strong hands-on experience with Empower LabX and other QC support systems along with solid understanding of configuration qualification and regulated laboratory environments.

Key Responsibilities

Provide day-to-day support for QC computerized systems including Empower and LabX.
Manage system configuration administration and troubleshooting to ensure uninterrupted QC operations.
Perform system qualification activities (IQ/OQ/PQ) in accordance with GxP and data integrity requirements.
Support change controls deviation investigations and CAPAs related to QC systems.
Execute periodic reviews access management and audit readiness activities.
Collaborate with QC QA IT vendors and cross-functional teams for system upgrades enhancements and validation work.
Ensure compliance with 21 CFR Part 11 ALCOA principles and applicable regulatory guidelines.
Prepare and maintain system documentation SOPs configuration specifications and validation deliverables.
Provide user training onboarding and technical guidance to QC laboratory personnel.
Support integration of QC instruments and data workflows as required.

Required Skills & Experience

5-8 years of experience in QC laboratories within pharmaceutical/biotech or regulated manufacturing.
Hands-on expertise with Empower (mandatory) and LabX (mandatory).
Proven experience in QC system support configuration and troubleshooting.
Strong background in computer system validation (CSV) and equipment qualification.
Solid understanding of GxP data integrity and ALCOA guidelines.
Experience supporting QC instrument systems (HPLC GC UV Karl Fischer etc.) is an advantage.
Familiarity with LIMS SDMS or other laboratory informatics platforms is a plus.
Strong documentation and stakeholder-management skills.