Job Description
We are seeking a Quality Compliance Specialist for our Pharmaceutical company in Waterford.
In this role, you will be responsible for quality compliance activities such as quality investigations, change management, supplier changes, documentation lifecycle, and compliance reporting. This position offers flexible and hybrid working arrangements.
The ideal candidate will hold a related degree in science or engineering and have 3 years' experience in a similar role. Previous experience in QC or Micro is desirable, with knowledge of cGMP and GDP, as well as exposure to quality systems in a regulated environment.
Main 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.
* Evaluate external and internal audits, ensuring effective coordination and support.
* Critically review procedures and practices.
* Lead projects to implement improvements.
* Consult with the Quality Assurance Representative to enhance RFT and audit readiness.