Quality Systems Specialist

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

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 transfision 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

Reporting to the Quality Systems Supervisor, the Quality Systems Specialist plays a key role in maintaining and continuously improving the site's Quality Management System (QMS). You will be responsible for managing quality system processes including document control, change controls, CAPAs, supplier qualification, supplier complaints, GMP training, and internal audits. Working closely with cross-functional teams, you will help ensure compliance with EU and FDA GMP requirements while supporting inspection readiness and driving quality excellence across the site.

What You Will Do

• 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.Help maintain audit readiness and ensure alignment with GMP regulations and health authority expectations.

What You Will Bring

• Bachelor's degree in Science, Pharmacy, or a related discipline.
• Strong knowledge of EU GMP, FDA regulations, and quality management systems.
• Minimum 2 years' experience in a Quality Systems, Quality Assurance, or Document Control role within a GMP-regulated pharmaceutical environment.
• 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.
• Strong technical writing, analytical, and problem‑solving abilities.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Ability to work independently while collaborating effectively with cross‑functional teams.

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

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3

Learn more about Grifols