Perfect QA Role for a Self-Starter
This key Quality Assurance position is ideal for a self-starter with a strong background in Quality Assurance and GMP.
Key Responsibilities:
* Oversight of QMS areas including Deviation Investigations, Change Control, CAPA management, Internal Audits, and Vendor Management.
* QA point of contact for Operations, providing guidance on manufacturing, validations, and new product introductions.
* Scheduling of GMP documentation review to support batch release, tech transfers, and new product timelines.
* Development, review, and approval of SOPs and other key documentation.
* Application of Quality Risk Management principles to drive compliance and efficiency.
* Leadership of cross-functional Operations workstreams, collaborating with teams like QC, QA, Manufacturing, and Engineering.
* Promotion of continuous improvement initiatives and support of external audits.
Requirements:
* Third-level qualification in a relevant Science or Engineering discipline.
* Experience 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.
* Team Player.