QA Reviewer

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

Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis; and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

We are currently seeking a QA Reviewer to support Quality Assurance activities within a pharmaceutical manufacturing environment. The successful candidate will be responsible for reviewing analytical and batch documentation to support the timely and compliant release of products. Working closely with QA, QC and Manufacturing teams, you will ensure analytical results and documentation meet GMP, quality and regulatory requirements. This role offers an excellent opportunity to join a growing quality team and contribute directly to product quality, compliance and patient safety

Key Responsibilities

• 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.

Who You Are

• 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.
• Experienced in investigating analytical issues and resolving out-of-specification results.
• Detail-oriented with strong documentation and data review skills.
• Highly organised with good computer literacy skills.
• Willing and available to travel for business purposes when required.

Where You Come From

• BSc, Masters degree, or equivalent relevant experience desirable.
• Ideally 5 years of experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry preferred.
• Experience working with analytical instrumentation, laboratory systems, and regulated testing environments.
• Knowledge of method development, validation, calibration, maintenance, and laboratory compliance activities.