QA Reviewer – GMP Analytics & Lab Compliance

CLS - Complete Laboratory Solutions; Limerick; On-site; EUR 45,000 - 65,000; Full time

Job summary

CLS - Complete Laboratory Solutions is seeking a QA Reviewer to support Quality Assurance activities within a pharmaceutical manufacturing environment. The successful candidate will review analytical and batch documentation to support timely and compliant release of products, working closely with QA, QC and Manufacturing to ensure results meet GMP, quality and regulatory requirements.

The role requires a strong technical background in HPLC and dissolution, experience with data integrity and

Qualifications

• BSc, MSc in a relevant science field is desirable.
• GLP/GMP laboratory experience in pharmaceuticals or medical devices preferred.
• Experience with analytical instrumentation and regulated testing environments.
• Strong documentation and data review skills essential.
• Willingness to travel for business when required.

Responsibilities

• Deputize for Analytical Team Leader, providing technical and problem-solving support.
• Maintain knowledge of HPLC, Empower, Winsotax, and LIMS.
• Receive and log samples, schedule testing and support release processes.
• Review calibration and maintenance documentation.
• Support development of new methods and validation activities.
• Review testing data and reports for release testing.
• Participate in audits and CAPA implementation.
• Comply with GLP, GMP, and safety requirements.
• Maintain a clean and organized laboratory.
• Provide monthly quality metrics as required.

Skills

HPLC troubleshooting

Dissolution analysis

Data integrity

Audit trail review

Documentation quality

Attention to detail

Travel readiness

Education

BSc or MSc in a relevant scientific field

Masters degree desirable

Tools

Agilent HPLC

Empower

Winsotax

LIMS

Job description

CLS - Complete Laboratory Solutions is seeking a QA Reviewer to support Quality Assurance activities within a pharmaceutical manufacturing environment. The successful candidate will review analytical and batch documentation to support timely and compliant release of products, working closely with QA, QC and Manufacturing to ensure results meet GMP, quality and regulatory requirements.

The role requires a strong technical background in HPLC and dissolution, experience with data integrity and