QA Operations Specialist (GMP & Aseptic) Shift

Complete Laboratory Solutions; Galway; On-site; EUR 42,000 - 54,000; Full time

Job summary

Complete Laboratory Solutions is seeking a QA Operations Executive to join a leading pharmaceutical manufacturing facility in Co. Galway.

The role provides day-to-day quality oversight of manufacturing operations, including real-time observation of aseptic activities and verification of GMP compliance. You will promote a strong quality culture, support continuous improvement, and act as a key contact between Manufacturing and Quality teams.

Qualifications

• Bachelor's degree in a science-related discipline.
• 1–3 years of relevant GMP-regulated pharmaceutical/biotech/medical device experience.
• Experience in quality assurance, manufacturing support, batch record review, or similar functions is desirable.
• Strong working knowledge of Microsoft Office applications (Word/Excel/PowerPoint).
• Experience with electronic document management systems is advantageous.
• Ability to interpret technical documentation and prepare reports.
• Exposure to deviation management, investigations, audit support or inspection readiness would help.
• Experience in sterile manufacturing, aseptic processing, or cleanroom environments is desirable but not essential.

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 preventive 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.

Skills

Attention to detail

Quality mindset

Communication skills

Independent worker

Team collaboration

Education

Bachelor's degree in science-related discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Electronic Document Management Systems

Job description

Complete Laboratory Solutions is seeking a QA Operations Executive to join a leading pharmaceutical manufacturing facility in Co. Galway.

The role provides day-to-day quality oversight of manufacturing operations, including real-time observation of aseptic activities and verification of GMP compliance. You will promote a strong quality culture, support continuous improvement, and act as a key contact between Manufacturing and Quality teams.