GMP Compliance Specialist

5 days ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €75,000

Job Title: GMP Compliance Specialist

Our client is seeking a talented individual to join their team as a GMP Compliance Specialist. This role offers an excellent opportunity to work in a dynamic environment, supporting the qualification and validation of manufacturing operations while ensuring compliance with regulations.

Key Responsibilities:
  • Serve as the site point of contact for Quality Assurance activities, providing technical expertise and guidance on QA and compliance matters.
  • Manage assigned areas of the Quality Management System (QMS) to ensure product manufacturing aligns with GMP and regulatory standards.
  • Oversee QMS elements including deviations, change control, CAPA, internal/external audits, customer complaints, vendor management, and batch records review.
  • Generate, review, and approve Standard Operating Procedures (SOPs) and other documentation related to areas of responsibility.
  • Conduct timely review and approval of site procedures and documentation to ensure alignment with GMP and regulatory requirements.
  • Review and approve validation protocols, reports, and associated documentation to ensure compliance with EU regulatory standards and internal procedures.
Requirements:
  • Strong understanding of GMP compliance and quality standards.
  • Excellent attention to detail with significant experience in document review.
  • Proficient in technical writing, including deviation reports and SOPs.
  • Strong time management and multitasking abilities.
  • Demonstrated ability to drive task completion, resolve issues, and maintain high-quality standards.
  • Excellent communication skills, both verbal and written.
  • Proficient in written and spoken English.
  • Strong team player with a collaborative mindset.
  • Third-level qualification in a relevant science or engineering discipline.
  • Minimum of 5 years' experience in a GMP-regulated Quality environment.
  • Experience in a Validation role with solid knowledge of the project lifecycle and current GMP regulations.

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