QA Operations Executive

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 QA Operations Executives (Shift) to join a leading pharmaceutical manufacturing facility in Co. Galway. This role provides day-to-day quality oversight of manufacturing operations, including real-time observation of aseptic manufacturing activities and verification of compliance with approved batch records, SOPs, and GMP requirements.

The successful candidates will promote a strong quality culture and contamination control mindset, support continuous improvement initiatives, and act as a key point of contact between Manufacturing and Quality teams. This position operates on a rotating shift pattern, alternating weekly between day and evening shifts.

Key Responsibilities

• Conduct checks and reviews of manufacturing operations to ensure GMP compliance and monitor factors that may affect product quality.

• Observe and assess aseptic practices and techniques during assembly, machine set-up, filling operations, interventions, and environmental monitoring activities.

• Collaborate with Manufacturing and Engineering teams to promote quality awareness and support continuous improvement initiatives.

• Monitor key quality indicators within manufacturing processes and identify preventative measures for potential quality risks.

• Perform spot checks of logbooks and manufacturing documentation to ensure compliance with Good Documentation Practices (GDocP).

• Assist with facility audits and Health Authority inspections.

• Support the delivery of quality-related training programmes.

• Participate in continuous improvement projects across manufacturing and quality operations.

• Support event reporting, investigations, and follow-up activities within the manufacturing area.

• Provide end-of-shift summaries and updates to management and quality leadership.

• Perform QA review of executed manufacturing batch records and associated chemistry and microbiology testing documentation.

• Support the processing of documentation for Qualified Person (QP) review and final disposition, where required.

• Carry out additional duties as assigned.

Who You Are

• A quality-focused professional with a strong attention to detail and commitment to GMP compliance.

• An effective communicator with excellent interpersonal and written communication skills.

• Organised and capable of managing multiple priorities within a fast-paced manufacturing environment.

• Comfortable working independently and taking ownership of assigned responsibilities.

• A proactive team player who collaborates effectively with cross-functional stakeholders.

• Committed to maintaining high standards of product quality, patient safety, and regulatory compliance.

• Flexible and willing to work a rotating shift pattern.

Requirements

• Bachelor's degree (or equivalent) in a science-related discipline.

• 1–3 years of relevant experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or related environment.

• Experience in quality assurance, manufacturing support, batch record review, or similar quality-related functions is desirable.

• Strong working knowledge of Microsoft Office applications, including Word, Excel, and PowerPoint.

• Experience working with electronic document management systems is advantageous.

• Ability to interpret technical documentation and prepare comprehensive reports.

• Exposure to deviation management, event investigations, audit support, or inspection readiness activities would be beneficial.

• Experience within sterile manufacturing, aseptic processing, or cleanroom environments is desirable but not essential.

• Own transport is required.

• Willingness and ability to work the rotating day and evening shift schedule.

Diversity, Equity & Inclusion

Complete Laboratory Solutions (CLS) is committed to creating a diverse, inclusive, and equal workplace where everyone is treated with respect and given the opportunity to succeed. We are proud to be an Equal Opportunities Employer and welcome applications from all qualified candidates regardless of background, gender, age, disability, ethnicity, religion, sexual orientation, or any other protected characteristic.