GMP Quality Systems Specialist – QMS & Compliance

Grifols; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Highly competitive salary

Group pension scheme

Private Medical Insurance

Education allowance

Wellness activities

Job summary

Grifols is seeking a Quality Systems Specialist to maintain and improve the site's QMS, including document control, CAPAs, supplier qualification, and internal audits. You will ensure EU GMP and FDA compliance while supporting inspection readiness across the site.

You will collaborate with Quality, Manufacturing, Engineering and Supply Chain, delivering GMP training and contributing to continuous quality improvements. A relevant degree and 2+ years' GMP experience are required.

Qualifications

• Bachelor's degree in Science, Pharmacy, or related discipline required.
• Strong knowledge of EU GMP and FDA regulations needed.
• Experience with quality management systems and document control.
• Experience supporting regulatory inspections and external audits.
• Excellent written and verbal communication skills.
• Proficient in Word, Excel, PowerPoint; ability to work cross-functionally.

Responsibilities

• Manage the site's Quality Management System documentation and archiving.
• Prepare and distribute QMS reports, metrics, and trends.
• Author and maintain SOPs and quality documentation.
• Coordinate Change Controls, CAPAs, supplier qualification, and supplier complaints.
• Support internal audit programmes and Annual Product Reviews.
• Deliver GMP induction and refresher training for site employees.
• Assist with regulatory inspections and customer audits and responses.

Skills

Quality Systems

Documentation control

Regulatory compliance

GMP knowledge

Audit support

Education

Bachelor's degree in Science/Pharmacy or related

Tools

Microsoft Office

Job description

Grifols is seeking a Quality Systems Specialist to maintain and improve the site's QMS, including document control, CAPAs, supplier qualification, and internal audits. You will ensure EU GMP and FDA compliance while supporting inspection readiness across the site.

You will collaborate with Quality, Manufacturing, Engineering and Supply Chain, delivering GMP training and contributing to continuous quality improvements. A relevant degree and 2+ years' GMP experience are required.