Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to join our team.
* Maintain quality management system processes in line with established procedures.
* Evaluate and ensure compliance with regulatory requirements, including cGMP.
The ideal candidate will possess knowledge of HPRA, EU, and US GMP/GDP regulations and international guidelines governing pharmaceutical manufacturing and quality systems.
* Provide quality oversight on manufacturing activities at third-party sites.
* Contribute to the development and maintenance of standard operating procedures (SOPs), document control, deviation and corrective action prevention (CAPA) management, and change control processes.
* Monitor and track quality issues and deviations, ensuring timely resolution and implementation of corrective actions.
* Report key performance indicators (KPIs) related to quality management, including document change control, complaints, and CAPA.
Skills and Qualifications:
* Bachelor's degree in a relevant field, such as life sciences or engineering.
* Minimum 3 years of experience in quality assurance, preferably in the pharmaceutical industry.
* Excellent understanding of quality management principles, including ISO 9001 and cGMP.
* Strong analytical and problem-solving skills, with ability to interpret complex data and make informed decisions.
What We Offer:
* A dynamic work environment with opportunities for professional growth and development.
* A competitive salary and benefits package.
* The chance to work with a talented team of professionals who share your passion for quality and excellence.