Quality Assurance Operations Manager

RECRUITERS; Dunboyne; On-site; EUR 65,000 - 90,000; Full time

Job summary

RECRUITERS is seeking a QA Operations Specialist for its state-of-the-art manufacturing facility in Dunboyne, Ireland. You will ensure GMP compliance, support batch documentation release, and provide QA oversight across manufacturing, engineering, supply chain and quality control.

In a multi-product biotech environment, you will drive continuous improvement, manage deviations and CAPAs, and collaborate with cross-functional teams to maintain high quality standards for clinical and commercial

Qualifications

• Degree or postgraduate qualification in Science, Pharmacy or related discipline.
• Minimum 3 years' experience within pharmaceutical/biotech.
• Knowledge of domestic and international cGMP regulations.
• Experience with batch record review and manufacturing operations.
• Experience with deviation management, CAPAs and change controls.
• Strong problem-solving and decision-making skills.
• Proactive with ability to manage competing priorities in a fast-paced manufacturing environment.

Responsibilities

• Provide QA oversight across manufacturing, engineering, supply chain and quality control operations.
• Support batch record review and release, ensuring accurate and compliant manufacturing documentation.
• Manage and support quality systems, including deviations, CAPAs and change controls.
• Work closely with cross-functional teams to resolve quality issues and support day-to-day manufacturing activities.
• Coordinate with internal Quality teams to ensure timely disposition and release of commercial drug substance.
• Support process and analytical technical transfers, as well as regulatory requirements.
• Ensure compliance with domestic and international cGMP regulations and company quality standards.
• Monitor site quality metrics, identify areas for improvement and support continuous improvement initiatives.
• Communicate quality-related issues effectively, ensuring appropriate escalation and resolution.

Skills

Batch record review

CAPA management

Change controls

cGMP knowledge

Quality systems

Team collaboration

Education

Degree in Science/Pharmacy

Job description

I’m currently recruiting for a QA Operations Specialist to join a leading pharmaceutical and biotechnology organisation at its state-of-the-art manufacturing facility in Dunboyne.

This is an excellent opportunity for an experienced Quality professional to work within a multi-product biotech environment, supporting both clinical and commercial manufacturing operations. You will play a key role in maintaining quality standards, ensuring GMP compliance and supporting the timely review and release of batch documentation.

Location: Dunboyne (onsite)

Key Responsibilities

• Provide Quality Assurance (QA) oversight across manufacturing, engineering, supply chain and quality control operations.
• Support batch record review and release, ensuring accurate and compliant manufacturing documentation.
• Manage and support quality systems, including deviations, CAPAs and change controls.
• Work closely with cross-functional teams to resolve quality issues and support day‑to‑day manufacturing activities.
• Coordinate with internal Quality teams to ensure timely disposition and release of commercial drug substance.
• Support process and analytical technical transfers, as well as regulatory requirements.
• Ensure compliance with domestic and international cGMP regulations and company quality standards.
• Monitor site quality metrics, identify areas for improvement and support continuous improvement initiatives.
• Communicate quality-related issues effectively, ensuring appropriate escalation and resolution.

What We’re Looking For

• A degree or postgraduate qualification in Science, Pharmacy or a related discipline.
• Minimum 3 years' experience within the pharmaceutical or biotechnology industry.
• Knowledge of domestic and international cGMP regulations.
• Experience in batch record review and manufacturing operations would be highly advantageous.
• Experience with deviation management, CAPAs and change controls is desirable.
• Strong problem‑solving and decision‑making skills, with the ability to work independently and as part of a team.
• A proactive approach, with the ability to manage competing priorities in a fast‑paced manufacturing environment.