CV-Library
Quality Assurance Specialist
SciPro are partnered with a rare disease focused clinical-stage biopharmaceutical company gearing up for commercialisation, to support the search for a QA Specialist based in Ireland. This is an exciting opportunity to join a small, agile team at a pivotal moment of growth ensuring quality and compliance as the company advances toward its next stage of evolution.
Working within a fully virtual environment, the QA Specialist will support the Quality Director in maintaining and improving the Quality Management System, overseeing GMP/GDP vendors, and ensuring operational excellence across the organisation. This is a hands-on role ideal for a self-starter who thrives in a fast-moving, entrepreneurial setting.
Key Responsibilities
Oversee and maintain the Quality Management System (QMS), ensuring compliance with GMP and GDP standards.
Update and manage SOPs and QA documentation.
Monitor vendor performance — ensuring change controls, CAPAs, and deviations are tracked and closed on time.
Support continuous improvement initiatives.
Key Requirements
Solid background in GMP/GDP within a biotech, pharmaceutical, or CDMO environment.
Hands-on experience with QMS management, vendor oversight, and system implementation.
Strong documentation, organisation, and communication skills.
Self-driven, pragmatic, and adaptable; comfortable in a small, virtual, and fast-evolving organisation. Able to work autonomously while collaborating closely with leadership