Quality Systems Specialist: GMP & Compliance

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

Pension scheme

Private medical insurance

Career development opportunities

Internal promotions

Education allowance

Wellness activities

Job summary

Grifols seeks a Quality Systems Specialist to maintain and improve the site QMS at Grange Castle, Co. Dublin. You will manage documentation, control systems, CAPAs, supplier qualification, and internal audits to ensure EU GMP and FDA alignment.

You will work with cross-functional teams across Manufacturing, Engineering and Supply Chain, delivering GMP training and supporting regulatory inspections to drive quality excellence.

Qualifications

• Bachelor's degree in Science, Pharmacy, or related discipline.
• Minimum 2 years' experience in Quality Systems, Quality Assurance, or Document Control in a GMP-regulated pharmaceutical environment.
• Strong knowledge of EU GMP, FDA regulations, and quality management systems.
• Experience managing or coordinating Change Controls, CAPAs, deviations, supplier qualification, and supplier complaints.
• Experience supporting regulatory inspections and external audits.
• Excellent written and verbal communication skills.

Responsibilities

• Manage the site's Quality Management System (QMS) documentation, including the Documentation Compliance Manager (DCM) system and document archiving.
• Prepare and distribute QMS reports, metrics, and compliance trends.
• Author, review, and maintain Standard Operating Procedures (SOPs) and other quality documentation.
• Coordinate and manage Change Controls, CAPAs, supplier qualifications, supplier performance reviews, and supplier complaints.
• Support the planning, coordination, and execution of internal audit programmes.
• Manage Annual Product Reviews and quality system reporting activities.
• Deliver GMP induction and refresher training programmes for employees across the site.
• Provide compliance-related training as required.Collaborate with Quality, Manufacturing, Engineering, Supply Chain, and other departments to support QMS activities.
• Support regulatory inspections and customer audits, including responses to audit observations.
• Drive continuous improvement initiatives to enhance quality system effectiveness and compliance.

Skills

EU GMP

FDA regulations

Quality management systems

Change Controls

CAPAs

Supplier qualification

Regulatory inspections

Document control

Communication

Writing

MS Office

Independent working

Education

Bachelor's degree in Science/Pharmacy or related

Tools

Microsoft Office

Job description

Grifols seeks a Quality Systems Specialist to maintain and improve the site QMS at Grange Castle, Co. Dublin. You will manage documentation, control systems, CAPAs, supplier qualification, and internal audits to ensure EU GMP and FDA alignment.

You will work with cross-functional teams across Manufacturing, Engineering and Supply Chain, delivering GMP training and supporting regulatory inspections to drive quality excellence.