Barinthus Biotherapeutics
Quality Systems Officer
Job Function:
Job Type:
Location:
Harwell
Based:
Closing date:
ABOUT THE ROLE
Key Responsibilities of the Role:
Working as part of the Quality team based in Harwell, UK, you will be responsible for:
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).
Additional Responsibilities of the Role:
Provide support during regulatory inspections and internal audits.
Supporting the internal and external (supplier) audit schedule and conducting of audits where appropriate.
Support Vendor Assurance activities (assessments of new and existing suppliers) including review of quality questionnaires as required.
Maintain and promote a state of inspection readiness at all times.
REQUIREMENTS
Qualifications and/or required experience to perform the role:
Essential
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
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.
Desirable
System Administrator experience of Veeva Vault Platform configuration management.
Veeva accredited certification of training.
Proven experience with the implementation, validation, and maintenance of a Computer System in a regulated industry (FDA or equivalent)
Knowledge of Clinical Trial processes across pharmaceuticals/biotechnology specifically as they relate to Clinical trials.
Barinthus Biotherapeutics' operates a hybrid working policy of 3 working days based in the Harwell office and 2 days working from home.
ABOUT THE COMPANY
At Barinthus Biotherapeutics, we’re always on the lookout for talented individuals who can contribute to our mission of advancing healthcare through innovative biotechnological solutions. If you don’t see a current opening that aligns with your skills and experience, we encourage you to send us a speculative CV at recruitment@barinthusbio.com. Please note that due to the high volume of CVs we receive, we may not be able to respond to every speculative application individually. Additionally, recruitment companies interested in partnering with us are advised to refer to the “Information for Recruitment Companies” section on our website for further guidance. We appreciate your interest in joining our team and look forward to potentially working together to drive progress in the biotech industry.
Barinthus Bio is an equal opportunity employer that is committed to diversity and inclusion in the workplace. As an employer, we are committed to ensuring representation of people from all backgrounds regardless of their gender identity or expression, sexual orientation, race, religion, ethnicity, age, neurodiversity, disability status, or any other aspect which makes them unique. We welcome applicants from all backgrounds to apply and would encourage you to let us know if there are steps, we can take to ensure that your recruitment process enables you to present yourself in a way that makes you comfortable.
HOW TO APPLY