GMP Computer Software Validation Engineer

Hillington, Glasgow

Overview

Do you enjoy technical writing? Maybe you enjoyed writing up your PhD? You might be working in Quality for a GMP organisation or you might be involved in software validation. This exciting new role might well appeal to you!

You’ll have an inquisitive mind, allowing you to quickly get up to speed on new concepts. Your keen eye will be able to appraise risk before you formulate test protocols to assure the quality of our software innovation. You’ll have a disciplined and methodical approach embracing the concept of do it once and do it right.

You’ll work closely with both our product development team and our regulated customers to ensure the validated state of the system is maintained with each new software release. Your thirst for knowledge and personal development will see you grow into a validation subject matter expert, keeping up to speed with the latest developments in the field.

Amici is the market leader of cloud-based software for biotech companies. We’re absolutely proud to support scientists every day in their endeavours to discover life changing cures for cancer, antibiotics or other rare diseases. Every contribution is highly valued and the growth of Amici continues to deliver a fantastic career development opportunities for our team. We are sure you will love working with our team, since our establishment in 2005 our team has grown to 50 fun people with an entrepreneurial spirit!

Key Responsibilities

  • Technical authorship of validation test protocol and related documentation (including IQ/OQ/PQ) utilising the principles of GAMP 5. We are happy to train you in any knowledge you need.
  • Pre-change notification to customers explaining the upcoming software changes and the associated impact on the validated system.
  • Distribution of validation documentation to our regulated customers.
  • Deputise for the Quality Manager in QMS related activities as and when required.

Desired Skills and Experience

  • Experience in technical document writing from industry and/or higher education, relevant industries include science, healthcare, IT, and law.
  • Investigative systematic mind able to get up to speed quickly with operational processes and control requirements.
  • Ability to effectively apply a risked based approach when decision making.
  • Strong IT skills with an ability to learn new software quickly.
  • Knowledge of software validation, GMP, and operations in a QMS environment would be advantageous.

Salary: Up to £35,000 (depending on experience)
Location: Hillington Park, Glasgow (close to Hillington East and West train station)

If this sounds like a good match and you want to learn more about the role, please email hr@amiciprocurement.com or telephone Lucy on 0141 810 2580.

To apply, please send your CV and a cover letter outlining your fit for this job to hr@amiciprocurement.com.

We encourage applications regardless of age, disability, gender identity, sexual orientation, religion, belief or race.

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