Job Title: Key QA Specialist
This key quality assurance role is designed for self-starters with a strong background in Quality Assurance and GMP. In this position, you will take ownership of Quality Assurance activities to ensure biological products are manufactured in strict compliance with GMP and regulatory standards.
You will collaborate across departments, manage critical QMS responsibilities, and contribute to continuous improvement initiatives.
Main Responsibilities:
1. Oversee QMS areas including Deviation Investigations, Change Control, CAPA management, Internal Audits, and Vendor Management.
2. Act as a QA point of contact for Operations, providing guidance on manufacturing, validations, and new product introductions.
3. Manage schedules for GMP documentation review to support batch release, tech transfers, and new product timelines.
4. Generate, review, and approve SOPs and other key documentation.
5. Apply Quality Risk Management principles to drive compliance and efficiency.
6. Lead cross-functional Operations workstreams, collaborating with teams like QC, QA, Manufacturing, and Engineering.
7. Drive continuous improvement initiatives and support external audits.
Requirements:
We are seeking a candidate with a third-level qualification in a relevant Science or Engineering discipline.
Essential requirements include experience working in a QA role (minimum 3 years) within a sterile GMP manufacturing environment.
Additionally, we require strong knowledge of QMS procedures, batch-related documentation, root cause investigations, and change control processes.
The ideal candidate will possess exceptional problem-solving, technical writing, and organisational abilities, along with being a team player.