QA Reviewer

SGS; Limerick; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

SGS is seeking an experienced QA Reviewer to join its Scientific In-sourcing team in Ireland. You will deputize for the Analytical Team Leader, provide technical support, and ensure compliance with GLP, GMP standards while maintaining GMP laboratory practices.

Responsibilities include handling HPLC and associated software (Empower, LIMS), method development, calibration, data review, audits, CAPA, and timely reporting.

Qualifikationen

• Minimum 5 years in a GLP/GMP analytical lab environment.
• Strong knowledge of HPLC, dissolution and standard instruments.
• Audit trail review and data integrity within regulated systems.
• Willingness to travel for business when required.

Aufgaben

• Deputize for Analytical Team Leader and provide technical support.
• Maintain knowledge of HPLC, Empower, Winsotax and LIMS.
• Carry out projects for new specs and methods.
• Receive, log samples; schedule testing; support release.
• Monitor equipment and complete documentation.
• Calibrate and maintain instruments; approve records.
• Review data and reports for release testing.
• Support audits and CAPA actions; comply with GLP/GMP.

Kenntnisse

GLP/GMP knowledge

Analytical laboratory experience

HPLC troubleshooting

Data integrity

Audits

Tools

Agilent HPLC

Empower

LIMS

Winsotax

Jobbeschreibung

SGS are the world’s leading testing, inspection and certification company SGS Group. We deliver solutions to a wide range of industry sectors in Ireland. Enjoy a truly rewarding career in a global, multicultural organisation with a proud heritage that has been making the world a better, safer place for over 140 years.

Our client services include providing SGS QC analysts and technical support staff on-site to fulfill staffing requirements (Scientific In-sourcing), all under the supervision and guidance of ISL technical and operational teams. Like all SGS personnel, they are committed to upholding stringent technical and GMP standards, ensuring the safety of medications for the multitude of patients relying on the products we test.

Due to growth, we have an exciting opportunity for an experienced QA Reviewer to join our growing Scientific In-sourcing team.

Job Description

• Deputize for the Analytical Team Leader as required, including providing technical and problem-solving support to the team.
• Maintain in-depth knowledge of Agilent HPLCs, Empower, Winsotax software and LIMS.
• Carry out project work associated with implementing new specifications and analytical methods required by pharmacopeial or customer requirements.
• Receive and log samples for testing, schedule testing activities and support laboratory release processes.
• Monitor and verify laboratory equipment and complete associated documentation.
• Perform instrument calibration and maintenance and complete associated records.
• Review and approve calibration and maintenance documentation as required.
• Support development of new methods and perform validation activities.
• Review and approve laboratory testing data and reports for release testing of finished products and raw materials.
• Review and approve laboratory investigations in a timely manner.
• Troubleshoot and investigate out-of-specification results.
• Participate in internal and external audits and support implementation of CAPA actions.
• Comply with GLP, GMP and safety requirements at all times.
• Maintain the laboratory in a clean and organised condition.
• Provide monthly reports and quality metrics as 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.

Additional Information

• Integrity
• Strong analytical ability and associated problem solving
• Good time management & attention to detail
• Results and performance driven
• Compliance with SGS policies and procedures
• Compliance with SGS and client policies and procedures

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, colour, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.