Quality Compliance Specialist — GMP Audits & Data

Grifols Shared Services North America, Inc

Dublin

On-site

EUR 60,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Annual performance-based bonus
Share-options scheme
Group pension scheme with company-m06
Private medical insurance
Career development opportunities
Succession planning

Job summary

Grifols Shared Services North America, Inc. is seeking a Quality Compliance Specialist to execute compliance within the QMS across the site and maintain awareness of system performance. You will support regulatory requirements, Grifols policies, and QA audits.

The role involves reporting, data analysis, CAPA drive, and cross‑functional collaboration to ensure external audit readiness and continuous improvement.

Qualifications

  • Bachelor's degree in a scientific field or equivalent.
  • Two to four years’ experience in the pharmaceutical/biotech industry.
  • Experience assisting or managing QA audits and inspections.
  • Good working knowledge of pertinent regulations and site SOPs.
  • Strong communication and facilitation skills.
  • Certification in auditing preferred.

Responsibilities

  • Provide reports on QMS metrics to site management.
  • Manage quality system integration, data integrity, and training requirements.
  • Support audits of suppliers/ Outsourced providers and external audits.
  • Coordinate self-inspection program and ensure CAPA is implemented.
  • Analyze quality data to improve product and process quality; share best practices.
  • Communicate with cross‑functional teams on compliance issues.

Skills

Word
Excel
PowerPoint
Auditing
Quality systems
Data analysis
Communication skills

Education

Bachelor's degree (B.A./B.S.) or equivalent
MSc in science, pharmacy or related discipline

Job description

Grifols Shared Services North America, Inc. is seeking a Quality Compliance Specialist to execute compliance within the QMS across the site and maintain awareness of system performance. You will support regulatory requirements, Grifols policies, and QA audits.

The role involves reporting, data analysis, CAPA drive, and cross‑functional collaboration to ensure external audit readiness and continuous improvement.

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