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Quality Assurance Specialist

3 months ago

United Kingdom Expert Executive Recruiters (EER Global) Full time

Quality Assurance Specialist – Relocation to Ireland

Our client is a global company with a site in Ireland and provides solutions for animal health and nutrition. The product line helps prevent, control, and treat diseases, improve animal health and performance, and maintain balanced nutrition.


We are seeking a Quality Assurance Specialist with a background in Pharma. This key role is an individual contributor role and perfect for a self-starter with professional and academic experience in QA and validation activities. The function is to ensure effective interaction with other departments such as Quality Control, Manufacturing, Engineering, and Technical Services.


Responsibilities:

  • Serve as primary QA point of contact for technical expertise, feedback, and guidance on QA and compliance issues.
  • Manage specific areas of the Quality Management System (QMS) to ensure adherence to GMP and regulatory standards.
  • Oversight of Deviation, Change Control, and CAPA management systems, as well as audits, complaints, and vendor management.
  • Review and approve SOPs and other relevant documentation.
  • Ensure timely review and approval of procedures to maintain GMP compliance.
  • Review and approve validation protocols/reports to meet EU regulatory expectations.
  • Maintain schedules for GMP/validation document review to support technology transfers and new product introductions.
  • Apply Quality Risk Management principles as necessary.
  • Lead QA activities in cross-functional project workstreams.


Requirements:

  • Background in Pharma.
  • Minimum 5 years’ experience in GMP Quality environment, including Validation function with knowledge of Project Life Cycle and cGMP Regulations.
  • Strong understanding of GMP compliance and quality standards.
  • Exceptional attention to detail and extensive document review experience.
  • Proficient in technical writing, including deviation reports and SOPs.
  • Effective time management and multitasking abilities.
  • Proven ability to drive task completion, troubleshoot effectively, and maintain meticulous attention to detail.
  • Excellent communication skills, both verbal and written, with proficiency in English.