Description
Our innovative Medical Device client are introducing a unique medical device to the market and are looking for a QA Specialist to join their growing company. This platform technology product is in the final stages of development and they are aiming to complete/run registration lots in the coming 6 months in the US and the EU.The successful candidate will represent our client in several separate UK based CMO sites, from formulation and aseptic filling, to the assembly, testing and packaging of the device in another location.
As the QA Specialist you will be responsible for, but not limited to, the following:
• Overseeing/completing vendor audits
• Taking the product from registration through to process validation, from a Quality perspective
• Conduct analytical reviews of the CMO's and the product
• Co-ordinating and managing CMO’s, ensuring delivery on time and in budget
• Answering queries from vendors and troubleshooting to avoid delays
• Driving the project to completion and working with vendors to meet deadlines
Requirements
• Strong experience in a regulated Medical Device manufacturing environment
• Experience in aseptic filling line
• Experience / background in stability
• Experience with design through to commercialisation of a medical device desired
• A varied background working for a range of small, medium and large companies would be beneficial.
Commitment
2-3 days a week (may require full time hours for the first 4/6 weeks)
Location
UK based, splitting your time between CMO sites throughout the project and may require some European travel
If this long term opportunity, paying competitive rates, working with cutting edge technology is of interest, then please contact me immediately.