Quality Systems Officer

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 daniel.bailey@cpl.com