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Senior Document Controller

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
23 Jul 2021
Closing date
22 Aug 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job description:
 

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 offer:

 

 

 

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.

 

 

Company

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).  

Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise. 

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.comwww.oxbsolutions.com, and follow us on LinkedInTwitter and YouTube

Life at Oxford Biomedica

We value everyone’s unique contribution, we appreciate everyone’s individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It’s a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people’s futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business’ future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We’ll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning.  Our defined career pathways provide opportunities for everyone to achieve their career potential.  We make a difference, and so can you.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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