Compliance Expert

2 days ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €60,000 - €80,000
Senior Compliance Specialist Job Description

The primary objective of this role is to oversee the overall quality system and ensure adherence to regulatory requirements. The Senior Compliance Specialist will be responsible for coordinating activities related to internal/external quality issues/projects, driving continuous improvement initiatives, and mentoring the business with respect to relevant quality tools.

This position involves close collaboration with company-wide departments to ensure internal system compliance and that customer specifications are met. The successful candidate will have a strong understanding of quality systems such as ISO 13485 / 21 CFR Part 820 / 21 CFR Part 4 / EU GMP. Knowledge of 21 CFR Part 210 / 211 is an advantage.

Responsibilities
  • Oversee the quality management system and ensure compliance with regulatory requirements.
  • Coordinate activities related to internal/external quality issues/projects.
  • Drive continuous improvement initiatives.
  • Mentor the business with respect to relevant quality tools.
  • Closely collaborate with company-wide departments to ensure internal system compliance.
Required Skills and Qualifications
  • Must have a third level qualification in Engineering/Quality/Science.
  • Level 8 qualification in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
  • Must have 5+ years' work experience in Medical Device or Pharmaceutical Manufacturing Environment.
  • Excellent communication and written skills.
Benefits

West offers a dynamic work environment that promotes innovation, teamwork, and professional growth. Our comprehensive benefits package includes opportunities for career development, employee recognition programs, and a competitive compensation structure.

Others

This role requires a high level of attention to detail, excellent problem-solving skills, and the ability to communicate complex ideas effectively. If you are a motivated individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.

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