QA Reviewer, GMP/GLP Lab Compliance & Audits

Sgs; Munster; On-site; EUR 60,000 - 90,000; Full time

Job summary

SGS is seeking an experienced QA Reviewer to join its Scientific In-sourcing team in Ireland. The role involves deputising for the Analytical Team Leader, maintaining expertise on Agilent HPLCs, Empower, Winsotax, and LIMS, and performing method development, validations, and release testing.

You will review data, support audits, ensure GLP/GMP compliance, and contribute to CAPA actions while maintaining a high standard of documentation and traceability. Travel may be required.

Qualifications

• Minimum 5 years of experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry preferred.
• Strong technical knowledge with the ability to troubleshoot HPLC, dissolution and other standard analytical instrumentation.
• Proficient in audit trail review and data integrity assessment within regulated laboratory systems.
• Willingness and availability to travel for business purposes when required.

Responsibilities

• Deputize for the Analytical Team Leader and provide technical support to the team.
• Maintain knowledge of Agilent HPLCs, Empower, Winsotax and LIMS systems.
• Carry out project work implementing new specifications and analytical methods.
• Receive and log samples, schedule testing activities, and support release processes.
• Monitor and verify laboratory equipment and maintain records.
• Perform instrument calibration and maintenance and document results.
• Review calibration and maintenance documentation.
• Support development of new methods and validation activities.
• Review data and reports for release testing of finished products and raw materials.
• Participate in audits and CAPA actions.

Skills

HPLC troubleshooting

Empower

LIMS

GMP/GLP

Data integrity

Auditing

Tools

Empower software

Winsotax

LIMS

Agilent HPLC

Job description

SGS is seeking an experienced QA Reviewer to join its Scientific In-sourcing team in Ireland. The role involves deputising for the Analytical Team Leader, maintaining expertise on Agilent HPLCs, Empower, Winsotax, and LIMS, and performing method development, validations, and release testing.

You will review data, support audits, ensure GLP/GMP compliance, and contribute to CAPA actions while maintaining a high standard of documentation and traceability. Travel may be required.