Senior Quality Compliance Officer

1 day ago

Sligo, Sligo, Ireland beBeeQuality Full time €55,000 - €85,000
Quality Assurance Specialist

This role is focused on supporting the qualification and validation of manufacturing operations, ensuring compliance with GMP and regulatory standards.

Responsibilities:
  • Provide technical expertise, feedback, and guidance on QA and compliance matters, including validation strategies and risk management.
  • Manage Quality Management System elements 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 review/approval of manufacturing batch records.
  • Generate, review, and approve 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.
  • Maintain documentation schedules to support technology transfers and new product introduction timelines.
  • Apply Quality Risk Management principles to all applicable activities.
  • Act as QA lead on cross-functional project teams involving Operations, Quality Control, Engineering, and other departments.
  • Actively contribute to site-wide continuous improvement initiatives.
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.

The successful candidate will play a key role in our organisation's commitment to delivering high-quality products while ensuring compliance with regulatory standards. If you have the required skills and experience, please contact us for a confidential discussion about this opportunity.

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