Perfect QA role for a self-starter with a strong background in Quality Assurance and GMP In this key QA position, you'll take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards.
You'll collaborate across departments, manage critical QMS responsibilities, and contribute to continuous improvement initiatives.
Key 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.
What We're Looking For: 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.
Team Player: Excellent collaboration and communication skills across departments Apply now and take the next step in your QA career!
Keywords: QA Specialist, Quality Assurance Analyst, QA Technician, Quality Assurance Specialist, Quality Specialist, Quality Technician Quality Specialist, Quality Assurance Analyst Skills: Quality Assurance GMP Pharma