Senior Quality Assurance Specialist
We are seeking a detail-oriented Senior Quality Assurance Specialist to support compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations.
* Plan, schedule, and conduct internal and external audits of manufacturers, suppliers, laboratories, warehouses, and transporters to ensure adherence to regulatory standards.
* Review documentation and quality processes to guarantee compliance with GMP/GDP requirements.
* Evaluate quality management systems (QMS), including document control, deviation management, and corrective action plans.
* Identify non-compliance issues, recommend corrective actions, and ensure timely follow-up to prevent future occurrences.
* Prepare clear audit reports and collaborate with stakeholders on corrective action plans.
Qualifying Criteria
* Bachelor's degree in a science-related discipline, such as chemistry or biology.
* At least 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.
* Solid knowledge of GMP/GDP regulations, including HPRA, EU, and US standards.
* Excellent communication and problem-solving skills, with the ability to manage multiple priorities autonomously.
Benefits
* Opportunity to work in a dynamic team environment.
* Professional development and growth opportunities.
* A competitive compensation package.