Job Role Overview
We have an excellent opportunity for a highly skilled Compliance Specialist to join our Biotech Drug Substance Manufacturing Facility in Limerick.
This is an exciting role that will enable you to work with next-gen manufacturing technologies, advanced data collection and analysis platforms to improve safety, quality, productivity, and reduce variability.
Main Responsibilities:
* Identify opportunities for improvement in quality and compliance standards and implement strategies to achieve them
* Develop and maintain systems and processes used for Quality compliance
* Roll out site quality initiatives
* Provide guidance on documentation, compliance issues, and systems support to departmental colleagues and partnering lines
* Ensure timely delivery of high-quality records, investigations, and associated actions
* Monitor metrics and trends to enhance compliance standards meeting internal and external auditor expectations
Lead and support quality-based investigations and action outcomes, including on-time completion.
About You
Requirements:
* Bachelor's degree in a science-related subject (Micro/Chemistry/Biochemistry or equivalent)
* Minimum 5 years of relevant experience
* Experience in quality management systems
* A background in Quality Control laboratory processes is preferable