GMP QA Specialist – Aseptic Manufacturing & Compliance

Grifols; Dublin; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Highly competitive salary

Group pension scheme

Private Medical Insurance for the EMP

Career development opportunities

Succession planning and internalPromos

Education allowance

Wellness activities

Job summary

Grifols is seeking a QA Manufacturing Specialist - Shop Floor to provide quality oversight for GMP manufacturing operations at the Albumin production facility. You will partner with Manufacturing, Maintenance, Automation and Quality teams to ensure safe, compliant production of Albumin products and support day-to-day operations and product release.

As SME in GMP compliance, you will coach operations, review GMP docs, lead deviations and CAPAs, and promote a culture of quality and aseptic

Qualifications

• Minimum Bachelors degree in a scientific discipline.
• Minimum 3 years’ experience in aseptic manufacturing within a GMP-regulated environment.
• Experience with QMS processes (paper and electronic systems).
• Knowledge of EU Annex 1 and FDA Aseptic Guide.
• Experience with deviations, investigations, and CAPAs.

Responsibilities

• Provide QA oversight for GMP manufacturing operations and ensure regulatory compliance.
• Support batch release readiness through timely review of quality documentation.
• Conduct shop floor activities (GEMBA walks) to maintain GMP compliance.
• Review, approve and author GMP documentation (SOPs, batch records, risk assessments, training).
• Support deviations, investigations, CAPAs, change controls, and continuous improvement.
• Act as primary QA contact for manufacturing operations and provide guidance on GMP and aseptic processing.
• Coach Manufacturing, Maintenance, and Quality teams on GMP, contamination control and aseptic best practices.
• Participate in risk assessments, validation activities, media fills, smoke studies, contamination control initiatives.
• Support inspections and maintain inspection-ready documentation.
• Contribute to operational improvement and project activities.

Skills

GMP knowledge

QA oversight

GEMBA walks

Documentation review

Deviations & CAPAs

Change controls

Aseptic processing

GMP compliance coaching

Risk assessment

Education

Bachelor's degree in a scientific discipline

Tools

QMS systems (Batch Records, LIMS, Veeva Vault, Trackwise)

RABS technology

Grade A/B cleanroom familiarity

Job description

Grifols is seeking a QA Manufacturing Specialist - Shop Floor to provide quality oversight for GMP manufacturing operations at the Albumin production facility. You will partner with Manufacturing, Maintenance, Automation and Quality teams to ensure safe, compliant production of Albumin products and support day-to-day operations and product release.

As SME in GMP compliance, you will coach operations, review GMP docs, lead deviations and CAPAs, and promote a culture of quality and aseptic