GMP QA Shop Floor Lead – Pharma Manufacturing

GRIFOLS, S.A.; Dublin; Presencial; EUR 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Highly competitive salary

Group pension scheme

Private Medical Insurance for the EMP

Education allowance

Wellness activities

Descripción de la vacante

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

As SME in GMP, you will coach teams, review GMP docs, lead deviations and CAPAs, and drive a culture of quality and continuous improvement in Grade A-D cleanroom environments.

Formación

• Bachelor's degree in a scientific discipline required.
• Minimum 3 years’ experience in aseptic manufacturing in GMP.
• Experience with QMS processes (paper and electronic).
• Knowledge of Annex 1 Sterile Manufacture and FDA Aseptic Guide.
• Experience with deviations, investigations and CAPAs.

Responsabilidades

• Provide QA oversight for GMP manufacturing operations and ensure compliance with cGxP and internal standards.
• Support batch release readiness through timely review of quality documentation and shop floor observations.
• Review and approve GMP docs including SOPs, batch records, risk assessments, and training records.
• Support deviations, investigations, CAPAs, change controls, and continuous improvement.
• Act as primary QA contact for manufacturing operations and guide aseptic processing activities.
• Coach and support teams on GMP, contamination control, and aseptic best practices.
• Participate in risk assessments, validations, media fills, smoke studies, and contamination control.
• Support inspections and maintain inspection-ready documentation.
• Contribute to operational improvements and project initiatives to enhance quality and performance.

Conocimientos

GMP compliance

Quality oversight

Attention to detail

Organizational skills

Educación

Bachelor's degree in scientific discipline

Herramientas

LIMS

Veeva Vault

TrackWise

Descripción del empleo

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

As SME in GMP, you will coach teams, review GMP docs, lead deviations and CAPAs, and drive a culture of quality and continuous improvement in Grade A-D cleanroom environments.