Key QA Position
In this key role, you will take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Responsibilities:
* Oversee Quality Management System (QMS) areas including Deviation Investigations, Change Control, Corrective Action and Preventative Action (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 Standard Operating Procedures (SOPs) and other key documentation.
* Apply Quality Risk Management principles to drive compliance and efficiency.
* Lead cross-functional Operations workstreams, collaborating with teams like Quality Control (QC), Quality Assurance (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 (minimum 3 years) within a sterile GMP manufacturing environment.
* Strong knowledge of QMS procedures, batch-related documentation, root cause investigations, and change control processes.
* Exceptional problem-solving, technical writing, and organisational abilities.
We're Looking For:
A self-starter with a strong background in Quality Assurance and GMP. A team player who is able to apply quality risk management principles to drive compliance and efficiency.