Job Description
Product Quality Professional - North Dublin
Core Tasks and Responsibilities:
* Contributing and leading in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation.
* Active in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, continuous improvement changes, and post-production (proactive surveillance).
* Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
* Focusing on process quality design improvements and updating quality system procedures to achieve fully compliant and lean processes.
Requirements:
* At least 5 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management.
* Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline or equivalent experience.
* Experience in being a part of teams and projects with strong communications and ability to work in technically complex multi-discipline areas across the whole supply chain.
* Cross-technology and cross-discipline collaboration skills and an aptitude for systems level thinking.
* Ability to write structured, concise technical English with high attention to detail and core understanding of statistical analysis and design of experiments experience.
* Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project).