Do you have experience in Computer Systems Validation (CSV), gained in a GMP manufacturing environment? Are you looking to progress your career within CSV, as part of a broader Validation role, including taking on team leadership responsibilities and joining an ambitious, pioneering biologics company? If so, this will be an excellent career opportunity for you.
A brand-new QA Validation Lead role has been created with a pioneering, ambitious company in West London, specialising in the production of DNA products to support the development of gene therapies. This is a newly-created permanent position, paying a very competitive salary, up to £65k (potentially slightly higher) depending on experience. While more experience is preferred, the company will also consider someone with intermediate-level CSV experience looking to step up into a Lead role.
You will need to have a background that has included validation of equipment, processes and software, ideally working with an electronic QMS such as Trackwise. This will be a fantastic career opportunity, with the chance to join a well-funded organisation that is doing something genuinely unique in the field of DNA, contributing to life-saving and life-changing advanced therapies.
Your role will include:
Implementing and maintaining an effective validation plan
Taking the lead for Computer Systems Validation (CSV) across the site
Supervising a Validation Officer, and growing the Validation team as part of the Quality group
Overseeing qualification maintenance work for established equipment and processes
Ensuring exceptional standards for document control
Maintaining and updating SOPs, experimental records, QMS documents, change controls and health & safety documents
Ensuring that external documents are distributed and controlled according to processes, and the document status is completed before deadlines to ensure their validity
Reviewing documents and data, writing quality reports and ensuring the meticulous checking and qualification of computer systems and equipment
Skills and Experience Required:
Ideally a BSc / MSc / PhD in a scientific, engineering, IT or technical discipline
A passion for Quality and developing QA / QMS processes
Experience in validating computer systems (eQMS, ERP, LIMS system or others) or equipment in a GMP environment, with an understanding of CSV protocols. This is an ideal role for someone who is looking to specialise in validating computer systems.
Excellent communication skills and ability to work with people at all levels
Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
This is a permanent position with an excellent salary and benefits. You will be based on site in West London (near Twickenham) as your primary location, though there will be occasional opportunities to conduct some of your work (perhaps 1 day a week) from home.