Software Validation Specialist

Permanent East Midlands Jobs & Advice in Medical/Pharmaceutical/Scientific
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Job Detail

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Job Description

On behalf of our client, we are looking to recruit a Software Validation Specialist to conduct validation of regulated software systems and other activities associated with the software system lifecycle.
The successful candidate will be an IT focused individual looking for an opportunity to take on and develop a newly created position, supporting the wider business. In return, this company can offer an excellent array of benefits including flexible working, medical insurance, health cash plan, dental insurance, retail vouchers and saving cards.
Whilst it is not a mandatory requirement that this individual is from a comparable Software Validation position previous life science regulatory experience is essential. This role would be well suited to experienced researchers who are very familiar with LIMS software.
Basic Requirements:
* MSc or BSc (Hons) in Chemistry/Biochemistry/ Biomedical Sciences or related subject or a qualification in Computer Science
* Experience working in a GLP facility
* Project management experience is essential
* Scientific data interpretation, reporting and presentation skills
* Knowledge of the studies and equipment used in metabolism, environmental fate and bioanalysis studies is advantageous
* Knowledge of Lablogic, Analyst, ExCALIBUR, and/or Watson suites of software is desirable
Duties and Responsibilities:
* Conduct validations of software and equipment in Metabolism
* Prepare and manage documentation for software validations
* Ensure compliance of computer systems with regulatory requirements
* Act as systems administrator for key software in the Metabolism department
* Support the implementation of tools and procedures to facilitate testing and document management of all software systems
* Ensure compliance of system validation SOPs with regulatory requirements
* Ensure consistency of systems validation SOPs with best practices of industry
* Ensure complete and accurate documentation of computer systems
* Participate in Sponsor audits
* Support continuous improvement of software systems
* Support focus teams to resolve compliance issues.
Agenda and its clients only recruit people who are passionate about animal care and welfare, people with integrity who are honest and trustworthy and who have a great work ethic. To enable us to hire the very best people we will conduct a full and comprehensive background and pre-employment screening as an essential part of the recruitment process

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