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Quality Assurance Specialist

3 weeks ago

Bray, Wicklow, Ireland beBeeQualityAssurance Full time

Job Title: Quality Assurance Specialist

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  • About the Job:
  • We are seeking a skilled Quality Assurance Specialist to collaborate with system owners in designing and maintaining compliant, efficient quality systems.
  • Your Key Responsibilities:
  1. Collaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle.
  2. Oversee data integrity and act as system administrator for key Quality Systems.
  3. Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements.
  4. Evaluate, approve, and monitor suppliers, including managing quality agreements.
  5. Lead change control processes and handle regulatory submissions.
  6. Support inspection readiness programs, including audits and regulatory inspections.
  7. Review and approve analytical method transfers, protocols, and related investigations.
  8. Manage GMP documentation, site validation plans, and the development of the site training system for GMP activities.
Requirements:
  • Bachelor's degree in pharmaceutical, biological, or similar field.
  • 4+ years of experience in the pharmaceutical industry.
What We Offer:
  • A dynamic work environment that fosters growth and learning.
  • The opportunity to work with a talented team of professionals.