QA Shop Floor Manufacturing Specialist

GRIFOLS, S.A.; Dublin; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Highly competitive salary

Group pension scheme

Private Medical Insurance for the EMP

Education allowance

Wellness activities

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP compliance

Quality oversight

Attention to detail

Organizational skills

Education

Bachelor's degree in scientific discipline

Tools

LIMS

Veeva Vault

TrackWise

Job description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary:

The QA Manufacturing Specialist - Shop Floor is responsible for providing quality oversight and guidance for GMP manufacturing operations within the Albumin production facility. The successful candidate will partner closely with Manufacturing, Maintenance, Automation, and Quality teams to ensure the safe and compliant production of Albumin products. Key responsibilities include supporting day-to-day manufacturing operations, reviewing and resolving quality issues, facilitating product release activities, and promoting a strong culture of quality and compliance. As a subject matter expert in GMP compliance, the QA Specialist will provide coaching and guidance to operational teams while ensuring adherence to industry regulations and aseptic manufacturing standards. A solid understanding of sterile manufacturing requirements, including EU GMP Annex 1 and aseptic processing principles within Grade A-D cleanroom environments, is essential for success in this role. What You Will Do:

• Provide QA oversight for GMP manufacturing operations, ensuring compliance with cGxP, EU Annex 1, FDA, and internal quality standards.
• Support batch release readiness through timely review and completion of quality documentation.Conduct shop floor presence activities, including GEMBA walks and manufacturing observations, to maintain GMP compliance and inspection readiness.
• Review, approve, and author GMP documentation, including SOPs, batch records, risk assessments, and training records.
• Support deviations, investigations, CAPAs, change controls, and continuous improvement initiatives.
• Act as the primary QA contact for manufacturing operations, providing guidance on quality, compliance, and aseptic processing activities.
• Drive quality culture by coaching and supporting Manufacturing, Maintenance, and Quality teams on GMP, contamination control, and aseptic best practices.
• Participate in risk assessments, validation activities, media fills, smoke studies, and contamination control initiatives.
• Support internal and external inspections and maintain inspection-ready documentation.
• Contribute to operational improvement and project activities to enhance quality, compliance, and manufacturing performance.

What You Will Bring:

• Minimum Bachelors degree in a scientific discipline.
• Minimum 3 years’ experience in aseptic manufacturing within a Quality or Manufacturing capacity in a GMP-regulated environment, preferably utilizing RABS technology (Grade A & B) is a requirement.
• Working experience with QMS processes, both paper-based and electronic systems (e.g., Batch Records, LIMS, Veeva Vault, Trackwise, etc.)
• Understanding of GMP regulation and guidance, notably Annex 1 ‘Sterile Manufacture’ and FDA Aseptic Guide.
• Working experience with deviations, Investigations, and CAPAs.
• Strong organisational and coordination ability
• High attention to detail and accuracy under pressure
• Ability to multitask and manage shifting priorities effectively
• Proactive and solution-oriented mindset

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Golf, Padel, Summer Event