Oxford BioMedica (UK) Limited
*Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.*
Oxford Biomedica’s Quality Assurance team is responsible for the companies quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control.
We are currently recruiting for a Senior Document Controller to manage a team of Document Controllers providing GxP documentation to support manufacturing, research and validation activities whilst ensuring maintenance of Document Control systems across the business.
*Your responsibilities in this role would be:*
* Management and development of a team of Document Controllers, ensuring efficient use of resource to meet company document management requirements.
* Maintenance of the company electronic and paper based document management systems ensuring that an efficient, and GxP compliant, document management service is provided across the business.
* Act as the core subject matter expert for the company document management system, be the primary point of contact for document management queries, and represent the system during regulatory and client audits/ inspections.
* Provide administration support for the electronic document management system and troubleshooting expertise when requested.
* Provide controlled copies of executable documentation such as batch records, logbooks and labels across the business
* Ensure the appropriate storage of GMP documentation. Acting as a primary company archivist by coordinating and preparing documentation for the offsite archive and recall documents upon request.
* Keep abreast of current GxP regulatory guidance and pharmaceutical industry standards pertaining to document management and ensure that the company system remains fully compliant
* Promotion of continuous improvement initiatives via the ongoing review of the current company document management systems and working practices, assessing the impact of the proposed changes by taking ownership of the associated change control documentation.
* Represent the document management function in internal projects and provide expertise when required.
* Initiation, ownership, investigation, root cause analysis, and implementation of corrective actions following the identification of non-conformances in relation to the usage of the company documentation system
* Development and deliverance of an effective document management training programme for staff across the business
*To be successful in this role, you will have the following skills and experience:*
* Previous line management experience would be beneficial
* GCSE (or equivalent) in English and preferably a scientific discipline
* Experience of documentation management (and supporting systems) in a regulated environment
* Good understanding of GxP requirements and Good Documentation Practice
* Proficient in the use of Microsoft Office Word, Excel, Outlook and Powerpoint
*Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.*
*Collaborate. Contribute. Change lives.*
We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.
We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.
Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.