Perfect QA Role for a Self-Starter
In this key Quality Assurance position, you will take ownership of quality activities to ensure biological products are manufactured in compliance with regulatory standards.
Key Responsibilities:
* Oversee Quality Management System (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 Good Manufacturing Practice (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:
* A third-level qualification in a relevant Science or Engineering discipline.
* Experience working in a Quality Assurance 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.
* A team player.