GMP Operations Specialist – Filling & Purification

Grifols, S.A

Dublin

On-site

EUR 55,000 - 75,000

Full time

7 days ago
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Benefits offered by this job

Group pension scheme
Private medical insurance
Education and professional development
Wellness and social initiatives

Job summary

Grifols, S.A seeks a Manufacturing Operations Support Specialist for our Dublin site. You will execute operational support activities, manage deviations, CAPAs and QRM, and act as SME across investigations, documentation, and training.

You will collaborate with QA, Engineering, and Supply Chain, ensuring compliant documentation and timely issue resolution while supporting continuous improvement initiatives in a cGMP environment.

Qualifications

  • Bachelor’s degree in Science or Engineering or related field.
  • 1–2 years of experience in GMP manufacturing, quality systems, or operational support.
  • Strong working knowledge of cGMP and quality systems (deviations, CAPA, change control, QRM).
  • Experience in technical writing and documentation (investigations, SOPs, reports).
  • Experience in biologics or regulated pharmaceutical manufacturing highly desirable.
  • Exposure to audit and inspection processes highly desirable.
  • Lean / Six Sigma knowledge or experience highly desirable.
  • Strong attention to detail and ability to solve problems effectively.
  • Good organizational skills with the ability to manage multiple priorities.

Responsibilities

  • Execute and support deviations, CAPAs, change controls, and QRM assessments.
  • Act as SME in areas of operational support (investigations, documentation, training, or QRM).
  • Support high-quality investigations with root cause analysis and corrective actions.
  • Ensure tasks are completed accurately, on time, and in compliance with procedures.
  • Provide technical guidance to Operational Specialists within the team.
  • Attend FAT or supplier sites for training and project support as required.
  • Manage project activities as needed.
  • Author and support closure of regulatory records (SOPs, QRM files, batch records).
  • Perform detailed record review for completeness and data integrity.
  • Provide day-to-day manufacturing operations support (batch records, on-floor troubleshooting, area readiness).
  • Escalate issues and risks to the Supervisor when appropriate.
  • Contribute to training materials and documentation improvements.
  • Participate in Lean, Six Sigma, or problem-solving initiatives.
  • Collaborate with Manufacturing, QA, Engineering, and Supply Chain teams.

Skills

GMP manufacturing
Quality systems
Deviations
CAPA
Change control
QRM
Technical writing
Investigations

Education

Bachelor’s degree in Science or Engineering

Job description

Grifols, S.A seeks a Manufacturing Operations Support Specialist for our Dublin site. You will execute operational support activities, manage deviations, CAPAs and QRM, and act as SME across investigations, documentation, and training.

You will collaborate with QA, Engineering, and Supply Chain, ensuring compliant documentation and timely issue resolution while supporting continuous improvement initiatives in a cGMP environment.

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