Senior Qa Specialist (extended Days)

medizinstellenmarkt.de

College Park, Dublin, Ireland
Cgmp compliance and quality oversight
Batch record and technical documentation review
Quality management system (qms) leadership
Step into a senior QA role where your expertise directly safeguards the quality, safety, and availability of life-changing biologic medicines, all within a high-performing team that values ownership, collaboration, and continuous improvement

Job Summary

  • Step into a senior QA role where your expertise directly safeguards the quality, safety, and availability of life-changing biologic medicines, all within a high-performing team that values ownership, collaboration, and continuous improvement.
  • You’ll partner closely with Operations, QC, Engineering, Facilities, Supply Chain and QPs to maintain compliance, support inspection readiness, and ensure uninterrupted patient supply.
  • This is a shift-based position operating across extended days and evenings, offering a dynamic working rhythm.

Matching Summary

Step into a senior QA role where your expertise directly safeguards the quality, safety, and availability of life-changing biologic medicines, all within a high-performing team that values ownership, collaboration, and continuous improvement.

Skills & Requirements

Must-have

  • cGMP compliance and quality oversight
  • Batch record and technical documentation review
  • Quality Management System (QMS) leadership
  • Inspection readiness and health authority engagement
  • SAP, EDMS, and MES proficiency
  • Shift work including extended days and evenings

Nice-to-have

  • Strong communication and presentation skills
  • Experience in Lean or Six Sigma environment
  • Leadership and interpersonal influencing skills
  • Ability to operate in international matrix environment
  • Continuous improvement mindset

Key Requirements

  • Significant biologics quality function experience
  • Degree in Pharmacy, Biology, Biotechnology, Engineering or related
  • Fluency in written and spoken English
  • Demonstrated auditing and process improvement success

Work Rights

Not specified

Tailored Resume

Cover Letter