Compliance Specialist Role
We are seeking an experienced professional to join our organization as a Compliance Specialist and support the implementation of GMP/GDP regulations.
The ideal candidate will be responsible for planning, scheduling, and conducting internal and external audits, reviewing documentation and quality processes, assessing quality systems, identifying non-compliance issues, and recommending corrective actions.
* Plan, schedule, and conduct internal and external audits to ensure compliance with regulations.
* Review documentation and quality processes to guarantee adherence to regulatory requirements.
* Assess quality systems, including document/change control, deviations, and CAPA management, to identify areas for improvement.
Required Qualifications:
* Bachelor's degree in a science-related field.
* 5+ years of experience in quality assurance or compliance within the pharmaceutical industry.
* Proven auditing experience in GMP/GDP environments.
* Strong knowledge of HPRA, EU, and US regulations.
Desirable Skills & Attributes:
* A detail-oriented professional with excellent leadership skills and the ability to engage teams.
* Strong problem-solving skills and the capacity to manage multiple priorities autonomously.
* A collaborative team player who can drive engagement across the organization.