Job Description
We are seeking a Quality Compliance Specialist for our Pharmaceutical company based in Waterford.
This role involves quality compliance activities, including quality investigations, change management, supplier changes, documentation lifecycle, and compliance reporting. The position offers flexible and hybrid working arrangements.
The ideal candidate will have a degree in science or engineering and 3 years of experience in a similar role. Experience in QC or Microbiology is highly desirable, along with knowledge of cGMP and GDP, as well as quality systems in a regulated environment.
Key Responsibilities:
* Perform and manage CAPA, Change Control, Investigations, periodic documentation lifecycle requirements, and report generation.
* Participate in the review of Quality Metrics for Quality Control.
* Contribute to the effectiveness, simplification, and continuous improvement of Quality Control procedures.
* Ensure effective coordination and support for external and internal audits.
* Perform critical reviews of procedures and practices.
* Identify and lead projects to implement changes and improvements.
* Consult with the Quality Assurance Representative to support and improve RFT and audit readiness.