Perfect QA Role for a Self-Starter
This is an exciting opportunity for a self-starter with a strong background in Quality Assurance and GMP to take ownership of Quality Assurance activities.
About the Job
You will be responsible for ensuring biological products are manufactured in strict compliance with GMP and regulatory standards. This key QA position requires collaboration across departments, management of critical QMS responsibilities, and contribution to continuous improvement initiatives.
Main Responsibilities
* Oversee QMS areas including Deviation Investigations, Change Control, CAPA management, Internal Audits, and Vendor Management.
* Act as a QA point of contact for Operations, providing guidance on manufacturing, validations, and new product introductions.
* Manage schedules for GMP documentation review to support batch release, tech transfers, and new product timelines.
* Generate, review, and approve SOPs and other key documentation.
* Apply Quality Risk Management principles to drive compliance and efficiency.
* Lead cross-functional Operations workstreams, collaborating with teams like QC, QA, Manufacturing, and Engineering.
* Drive continuous improvement initiatives and support external audits.
Requirements
* Third-level qualification in a relevant Science or Engineering discipline.
* Experience of working in a QA role (min 3 years) within a sterile GMP manufacturing environment (essential).
* Strong knowledge of QMS procedures, batch-related documentation, root cause investigations, and change control processes.
* Exceptional problem-solving, technical writing, and organisational abilities.
About Us
We value candidates who are passionate about quality assurance and committed to delivering exceptional results.