Overview Quality Systems OfficerOxfordshireUp to £55,000 per annum Key Responsibilities• System Administrator/Vault Owner in Veeva Vault (Quality & Clinical) supporting UK and US sites.• Train, support and advise Veeva end users on system requirements and workflows.• Responsible for day-to-day troubleshooting and supporting end user queries within Veeva Vault.• Manage the mandatory Veeva Releases, performing impact assessments and the appropriate level of validation via Change Control in order to maintain the system's validated state within strict deadlines.• Perform continuous improvement activities by designing and implementing configurations within Veeva Vault for new business requirements or proposed changes using Design/Build/Test/Production lifecycle processes.• Participate where required, in the authoring and execution, or review and approval of computer software validation testing in accordance with GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance.• Create and run reports, to support Veeva performance reporting.• Be involved with other computer software validation projects as quality lead.• Author, review or approve a variety of quality documentation (SOPs, Validation protocols, Deviations, CAPAs, Change Controls).
Essential Skills• A degree in Life Sciences, Engineering or Computer Science (or equivalent experience).• Experience in a Quality Assurance role.• Experience in Veeva Vault especially Veeva QualityDocs.• Awareness of Computer System Validation.• Knowledge of GxP standards eg MHRA, FDA, ICH, GAMP.• Good communication and interpersonal skills, therefore comfortable communicating at all levels of the business.• Ability to work independently to complete assignments within defined time constraints in addition to working collaboratively as part of a team.• Proficient knowledge and understanding of Microsoft Office Applications (Word, Excel, PowerPoint, SharePoint, Teams, Outlook) and/or other relevant software programs.
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