Document Controller and Veeva System Administrator - Harwell, United Kingdom - Vaccitech

Vaccitech
Vaccitech
Verified Company
Harwell, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

The role


The Document Controller will be the Systems Administrator for the company's global electronic Quality Management System (eQMS), Veeva, currently used for document management and training.

This person will also be responsible for helping with the implementation and administration of further Veeva Quality System modules such as Quality Events, CAPAs and Change Control.

The Document Controller will report to the Director of Quality Assurance.


We are looking for an individual that is self-motivated and willing to own their own training and development, which includes liaising with Veeva support staff.

The person needs to be inquisitive, and solution focused and willing to train other employees.


This person needs to be computer literate with a strong interest in learning new computer systems and finding out how they work.


Key areas of responsibility will include, but are not limited to:

  • Serve as Subject Matter Expert (SME) for Veeva Vault and to act as the company's Administrator for Veeva.
  • Provide oversight and support to the Director of Quality for Vaccitech's global quality system, supporting both North America and the U.K.
  • Support Quality Systems governance of Quality Events (i.e., deviations, nonconformances, etc.), CAPAs, Change Controls and Quality Metrics.
  • Review and approve document change controls and procedures, which include, but are not limited to: SOP's, policies, controlled forms, and templates.
  • Creation of training curricula within Veeva.
  • Generate and revise SOPs and associated documents, including templates as needed, including oversight of SOP biennial review compliance.
  • Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
  • Archive (or oversee the archiving) documentation on behalf of the Quality Department.
  • Perform or assist training on QA topics to the organisation to include staff induction training and Veeva.
  • Manage Veeva general releases and refreshes of the Veeva environments.
  • To be the main liaison between Vaccitech and Veeva.

Qualifications and/or experience required to perform the role

  • Previous experience in working in a highly regulated environment such as biotechnology, pharmaceuticals, or medical devices.
  • Experience in electronic Quality Management Systems, Document Management Systems, and Training Management Systems. Highly desirable is previous experience with Veeva.
  • Highly motivated with a positive attitude.
  • Good communication skills and ability to work well with others.
  • Previous experience/ roles requiring strong computer skills and learning new computer systems.
  • Experience in training others in computer systems is desirable.

What we can offer you
Vaccitech is a great place to work. We encourage an entirely flat structure with an open-door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. This role would suit an experienced QC Chemist who wants to move into a QA career path.

As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us.

We offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 6% pension contributions matched by the company.

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