Software Validation and Quality Manager - on-site or remote
Software Validation and Quality Engineer required for a start-up based in Stirling, with remote/flexible working options available.
The role is the first of its kind in the company and is one that is expected to develop and grow, with unlimited opportunities as the function continues to develop. You will play a big part in how the position develops and there is an expectation that down the line that this role could develop into a Senior Manager. This area of the business is becoming increasingly important for the business and will continue to grow with your help.
On a day to day basis you will be expected to validate and test the computer and software systems to ensure they are fit for purpose, in accordance with international standards. You will be solely responsible for performing all validation activities across their ERP system, software development tools, and cloud applications and will be someone who is passionate about ensuring best practice is implemented throughout the business.
You'll be someone who is a strong and confident communicator who is able to champion the processes necessary to validate the various tools to a high standard. You'll also be someone who understands that time is of the essence and can produce quality work in a fast-paced environment. You might be someone who has done something similar across the pharmaceutical or medical devices industry.
You will have experience across most of the following:
** Perform validation of cloud and implementation tools (including tools such as Jira, Github etc.)
** Manage the process from end-to-end, working with suppliers to resolve validation issues
** Meeting international standards such as ISO13485, or similar
** Meeting country specific regulations
** Good automated manufacturing practice (GAMP5) for the validation of automated systems
This is an opportunity to join a fast-growing company who are working on brand new projects and are developing real cutting-edge products. What they are building is revolutionary and will better the lives of millions of people across the globe - a big claim, but a true one! The product is now ready and has just gone to market, and so this is a period of really positive growth for the company and a great time to join them.
They look after their staff well, with access to the latest kit, flexible working and real progression opportunities across the entire organisation.
Salary and Location
The role is based primarily at their Stirling HQ, but the company would be open to someone working remotely dependant on experience / set-up at home. Their head office has plentiful parking and is easily commutable from Edinburgh, Falkirk, Glasgow and surrounding areas.
Travel around the UK will be a part of this role but is only likely to be three to four days per month.
They are able to offer a generous salary of up to £60,000 for the right person, as well as a strong benefits package on top of this.
If this opportunity is of interest, please do apply or reach out to Erin Donnelly at Cathcart Associates for more information.
Quality Engineer / Computer validation / Software validation / CVS / ISO13485 / FDA 21 CFR 820 / 21 CFR 11 / GxP / GAMP / GAMP5
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