QC Analyst QC Systems Specialist

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading technology solutions provider in Singapore is seeking a QC Analyst to support laboratory operations and QC systems management. The ideal candidate will have 5-8 years of experience in regulated environments and expertise in Empower and LabX systems. Responsibilities include managing system configurations, executing qualification activities, and ensuring compliance with GxP standards. This full-time role offers a challenging environment with opportunities for professional growth.

Qualifications

• 5-8 years of experience in QC laboratories within pharmaceutical/biotech.
• Hands-on expertise with Empower and LabX mandatory.
• Solid understanding of GxP data integrity and ALCOA guidelines.

Responsibilities

• Provide day-to-day support for QC computerized systems.
• Manage system configuration administration and troubleshooting.
• Perform system qualification activities in accordance with GxP requirements.
• Execute periodic reviews and audit readiness activities.

Skills

Empower

LabX

QC system support

Computer system validation (CSV)

Stakeholder management

Tools

HPLC

GC

UV

Karl Fischer

LIMS

SDMS

Job description

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.

Employment Type: Full Time

Experience: years

Vacancy: 1