Pharmaceutical Compliance Specialist
We are seeking an experienced pharmaceutical compliance specialist to support our client's team and ensure compliance with GMP/GDP regulations in a fast-paced, dynamic environment.
Key Responsibilities:
* Plan, schedule, and conduct internal and external audits of manufacturers, suppliers, labs, warehouses, and transporters to ensure quality and compliance.
* Review documentation and quality processes to guarantee adherence to HPRA, EU, and US GMP/GDP standards.
* Assess quality systems, including document/change control, deviations, and CAPA management, to identify areas for improvement.
* Identify non-compliance issues, recommend corrective actions, and ensure timely follow-up to maintain regulatory compliance.
* Prepare clear audit reports and liaise with stakeholders on CAPA plans to drive continuous improvement.
* Contribute to the development and implementation of quality management systems, SOPs, and quality processes to enhance operational efficiency.
Qualifying Criteria:
* Bachelor's degree in a science-related field, such as chemistry or biology.
* 5+ years of experience in quality assurance or compliance in the pharmaceutical industry.
* Proven auditing experience in GMP/GDP environments, with a strong understanding of regulatory requirements.
* Strong knowledge of HPRA, EU, and US regulations, including GMP/GDP standards and guidelines.
* Solid understanding of manufacturing and lab processes, validation, and distribution.
Required Skills & Qualifications:
* A detail-oriented professional with excellent communication and interpersonal skills.
* Strong problem-solving skills and the ability to manage multiple priorities autonomously.
* Collaborative team player with a proactive approach to driving engagement across the business.