Quality Excellence Specialist
Empowering excellence in quality management is a crucial role at our organization. We seek an experienced specialist to drive quality excellence and ensure the manufacture and release of combination products meet rigorous standards.
The ideal candidate will:
* Develop and implement site quality systems, encompassing SOPs, document control, change control, investigations, CAPA, internal auditing, vendor qualification & management, material and batch disposition, complaints, and annual product review.
* Provide QA support to ensure inspection readiness and collaborate with key stakeholders, including engineering, validation, manufacturing, regulatory, and global quality teams.
* Maintain regulatory compliance and generate supporting documents, including API declarations, approved product lists, and oversight reports.
This dynamic role requires a candidate with:
* An effective combination of industry experience, education, and skills, including EU and US regulatory knowledge.
* Experience in designing and implementing quality systems or start-up environments.
* High proficiency in Microsoft Office applications and electronic systems/databases.
* Excellent team working, communication, and time management skills, with the ability to work under pressure and adapt to changing environments.
Our organization offers a competitive salary, benefits, and inclusive environment where you can make a meaningful impact on people's lives.