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Expert Quality Specialist

2 weeks ago

Bray, Wicklow, Ireland beBeeQuality Full time
Quality Assurance Expert

We are seeking a highly skilled Quality Assurance Expert to join our team.

Job Description:

The successful candidate will be responsible for designing and maintaining compliant, efficient quality systems that support the product lifecycle. This includes overseeing data integrity, acting as system administrator for key Quality Systems, and managing site Quality System Governance. Additionally, the candidate will evaluate, approve, and monitor suppliers, including managing quality agreements. They will also lead change control processes, handle regulatory submissions, and support inspection readiness programs, including audits and regulatory inspections.

Responsibilities:
  • Collaborate with system owners to design and maintain compliant quality systems
  • Oversee data integrity and act as system administrator for key Quality Systems
  • Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements
  • Evaluate, approve, and monitor suppliers, including managing quality agreements
  • Lead change control processes and handle regulatory submissions
  • Support inspection readiness programs, including audits and regulatory inspections
Requirements:
  • Bachelor's degree in pharmaceutical, biological, or related field
  • 4+ years of experience in the pharmaceutical industry
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills
Skills:
  • Quality management
  • GMP auditing
  • Systems