Biomaterials QA Specialist

Biomaterials QA Specialist - Grow into an Expert

Do you want to join a company that is the global leader in their field? My client has over 100 years experience in bioplastics, medical devices, pharmaceuticals and nutrition and is searching for a biomaterials QA specialist to join their team.

How would you grow into an expert? With training! They invest in relevant courses related to your particular discipline, which will give you all the opportunity to grow into an industry expert. Their internal experts provide training in biomaterials which are used not just in pharma/medical devices, but in other industries as well. However, the real beauty about the company is that they empower their employees to take initiative to turn their ideas into reality and make a real, tangible difference.

Lastly, they are a truly international company that embraces diversity. By joining them you will enter into a company where you can feel pride in your achievements and develop your career with global prospects.

Responsibilities:

• Maintain and improve the QMS in compliance with ISO 9001
• Develop and implement a Data Integrity Compliance Program + Risk Assessments
• Monitor/Identify developments in legislation (FDA, EMA, ICH, USP…etc)
• Release of raw materials and final products to the market
• Support QA with Audits, CAPA's, Change Control, Deviations, Root-Cause Analysis and Complaint Handling
• Support QA/RA by following up on requests in business development projects

Requirements:

• Seasoned professional in pharmaceutical, medical devices, food or an FDA regulated industry
• Thorough knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820
• Life Sciences degree or other relevant area
• Able to travel 10-20%
• Experience in implementation and validation guidelines for computerised systems (GAMP5, 21 CFR/11, ICH validation, Eudralex)

Desirable:

• Dutch speaking
• Regulatory Affairs experience
• Quality Control experience

If this job appeals to you please apply here or send your CV to me, Jared Holmes, on the NonStop Consulting website. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxemburg, Switzerland, US, Romania and the Czech Republic. Please visit our website for a full list of the niche markets we cover.