Senior QA Compliance Specialist

1 week ago

Loughrea, Galway, Ireland beBeeQuality Full time €55,000 - €75,000
Job Description

The successful candidate will lead and manage the day-to-day Quality Assurance activities within designated Production areas. This role is responsible for delivering on all aspects related to quality compliance, executing tasks such as creating and executing quality documents, including change control, deviations, CAPA, FMEA, while ensuring compliance to the Quality Management System.

Key Responsibilities:

  • Ensure timely preparation, review, and approval of all quality reports within departmental deadlines.
  • Lead, create, and review process investigations and risk assessment documents, ensuring thorough documentation and implementation of appropriate corrective actions.
  • Initiate, investigate, and manage compliance documentation including Change Controls, Deviations, SCARs, Reject Notices, and CAPAs.
  • Conduct routine quality audits within the department to verify compliance and proactively address any emerging issues.
  • Develop and update Quality Procedures, including Standard Operating Procedures (SOPs), in alignment with current GMP regulations.
  • Drive continuous improvement initiatives to enhance the company's Quality and GMP standards, with a focus on strengthening the overall quality system.
  • Support and, when required, lead quality-related projects within the department, collaborating effectively with multidisciplinary teams.
  • Participate in self-inspections, internal audits, and regulatory inspections, ensuring timely implementation of corrective actions.
  • Contribute to Change Control meetings and actively participate in monthly Quality Management & Review meetings.

Required Skills and Qualifications

To be successful in this role, you should have:

  • A Bachelor's degree in a quality or science-related discipline.
  • Lean/Six Sigma certification and statistical analysis knowledge are highly desirable and considered advantageous.
  • Minimum of 4–5 years' experience in a GMP-regulated manufacturing environment, with a strong working knowledge of EU GMP and US FDA guidelines.
  • Prior experience in the pharmaceutical industry is preferred; however, relevant experience in the medical device sector will also be considered.
  • Strong report writing skills and proficiency in IT systems.
  • Proven hands-on experience in delivering a best-in-class Quality Assurance function in a similar role.

Benefits

This role offers excellent opportunities for professional growth and development, as well as a chance to work with a dynamic team.

Others

We value diverse experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.

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