Job Description
Quality Systems Specialist Role
We are seeking a Quality Systems Specialist to support the manufacture and release of Combination products. The successful candidate will develop and implement site Quality Systems, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.
The role will also provide QA support to site to ensure Inspection Readiness. Collaboration with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality is essential.
Main Responsibilities:
* Develop and implement site Quality Systems.
* Provide QA support to site to ensure Inspection Readiness.
* Collaborate with key stakeholders.
* Support operation of the site Training system.
* Ensure compliance with regulatory requirements.
* Support implementation of Continuous Improvement program.
About Your Skills & Experience
We are looking for a candidate with an effective combination of qualifications, skills and experiences.
* Educated to degree level with proven industry experience.
* Working knowledge of EU & US regulatory requirements.
* Experience in designing and implementing quality systems an advantage.
* High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.
* Good team working and strong communication skills.
Benefits
We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.