QA Manufacturing Specialist

Grifols, S.A; Dublin; In loco; EUR 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Highly competitive salary

Group pension scheme

Private Medical Insurance

Education allowance

Wellness activities

Descrizione del lavoro

Grifols, S.A. in Ireland is seeking a QA Manufacturing Specialist to provide quality oversight on the shop floor for GMP operations in the Albumin facility.

You will partner with Manufacturing, Maintenance, Automation and Quality teams to ensure safe, compliant production and timely batch release. Required: a bachelor’s in a scientific field and 3+ years in aseptic GMP manufacturing, experience with QMS systems (LIMS/Veeva/Trackwise) and deviation/CAPA processes; strong attention to detail and

Competenze

• Bachelor’s degree in a scientific discipline.
• 3+ years’ aseptic GMP manufacturing experience.
• Experience with QMS processes (paper/electronic).
• Understanding of Annex 1 and FDA guidance.

Mansioni

• Provide QA oversight for GMP operations and cGxP compliance.
• Support batch release readiness through timely QA reviews.
• Review and approve GMP documentation and records.
• Assist deviations, investigations and CAPAs, change controls.
• Coach ops teams on quality, asepsis and contamination control.
• Participate in risk assessments and validation activities.
• Maintain inspection-ready documentation and support inspections.

Conoscenze

Aseptic manufacturing

GMP compliance

QMS processes

GEMBA walks

CAPA investigations

Batch records

Risk assessments

Documentation review

Formazione

Bachelors degree in science

Strumenti

LIMS

Veeva Vault

Trackwise

Descrizione del lavoro

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