Quality Systems Officer
Oxfordshire
Up 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.
If interested, please send CV to