QA Specialist - Sterile Manufacturing

Life Science Recruitment; Munster; On-site; EUR 40,000 - 60,000; Full time

Job summary

Life Science Recruitment is seeking a QA Specialist for a Sterile Manufacturing site in Waterford, Ireland. You will ensure products are manufactured, stored and packaged in compliance with cGMP and participate in audits and continuous improvement.

The role requires a science-based degree and at least two years of QA or GMP experience; sterile/aseptic manufacturing experience is highly desirable. You will review batch docs, CAPAs and deviations, and provide quality guidance across the site.

Qualifications

• Degree in science, quality, engineering or related discipline.
• Minimum two years in QA or GMP quality role.
• Experience in pharmaceutical/regulated manufacturing environment.
• Strong knowledge of cGMP requirements.
• Sterile/aseptic manufacturing experience desirable.
• Experience reviewing deviations, investigations, CAPAs and batch documentation.

Responsibilities

• Act as quality point of contact for assigned manufacturing systems and processes.
• Provide quality guidance to manufacturing and supporting departments.
• Review batch documentation, investigations and GMP records.
• Identify quality concerns and support their resolution.
• Support deviation investigations and CAPA closures.
• Collaborate to close audit findings and quality actions.
• Assist in procedures, batch records and controlled docs.
• Deliver GMP training packages.
• Perform internal audits and participate in supplier/regulatory audits.
• Monitor Right First Time performance and quality trends.
• Address recurring documentation and compliance issues.

Skills

Quality Assurance

GMP knowledge

Documentation review

CAPA investigations

Internal audits

Education

Third-level qualification in science/quality/engineering or related

Job description

QA Specialist | Sterile Manufacturing | Waterford

We’re currently recruiting for an excellent Quality Assurance opportunity with a leading global pharmaceutical manufacturer based in Waterford.

The position will form part of the site Quality Assurance team, ensuring that products are manufactured, stored and packaged in accordance with cGMP requirements.

This role would be particularly relevant for a QA professional with experience supporting sterile, aseptic or other highly regulated pharmaceutical manufacturing operations.

Duties

• Act as the quality point person for assigned manufacturing systems and processes.
• Provide quality guidance and feedback to manufacturing and supporting departments.
• Review batch documentation, investigations, reports and GMP records within agreed timelines.
• Identify quality concerns and support their resolution based on product and compliance risk.
• Support deviation investigations and ensure product-impacting deviations are closed before release.
• Work with relevant departments to ensure timely closure of CAPAs, audit findings and quality actions.
• Participate in the preparation and review of procedures, batch records and controlled documentation.
• Support the development and delivery of GMP training packages.
• Perform internal audits in accordance with the site audit schedule.
• Participate in supplier and regulatory audits where required.
• Monitor Right First Time performance and quality trends.
• Work with manufacturing departments to address recurring documentation and compliance issues.
• Support continuous improvement initiatives across the site quality system.
• Perform critical and constructive reviews of procedures and manufacturing practices.
• Ensure compliance with cGMP and site safety requirements at all times.

Education and Experience

• A third‑level qualification in science, quality, engineering or a related discipline.
• A minimum of two years’ experience in Quality Assurance or a comparable GMP quality role.
• Previous experience working within a pharmaceutical, biotechnology or other regulated manufacturing environment.
• Strong working knowledge of cGMP requirements.
• Sterile or aseptic manufacturing experience is highly desirable.
• Experience reviewing deviations, investigations, CAPAs and batch documentation would be advantageous.

For further information, please contact Seán McCarthy on [phone] or [e-mail].