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Compliance Officer, Process R&D

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
4 Feb 2021
Closing date
4 Mar 2021

View more

Discipline
Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Our employees are able to develop their careers in exciting new medical technologies, and so can you.

Oxford Biomedica’s Process R&D team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development.  PR&D take processes from the laboratory “bench” scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.

We are currently recruiting for a Compliance Officer to join the team.  The purpose of this role is to work alongside the team to ensure the timely reporting of project outcomes and timely investigation into project related issues, ensuring compliance with internal procedures and GMP requirements where applicable.

Your responsibilities in this role would be:

  • Carry out and co-ordinate data integrity checking of experimental records, technical reports, presentations and other technical documents.
  • Responsible for PR&D Data Integrity checking SOP.
  • Organise and facilitate investigations and root cause analysis into process and laboratory deviations.
  • Identify and implement effective corrective and preventative actions to identified root causes.
  • Conduct regular inspections of the PR&D laboratories.
  • Organise and facilitate individual and group training with regard to PR&D SOPs.
  • Lead updates to process documentation to capture new learnings and best practices.
  • Lead and promote process improvement ideas to increase the department’s efficiency.
  • Accountable for own performance in alignment with group objectives and deadlines.
  • Work in accordance with the OXB quality management system.

To be successful in this role, you will have the following skills and experience:

  • Graduate in a science based subject, and/or experience of working to GMP standard.
  • Previous experience in the pharmaceutical industry/relevant in an MHRA/FDA regulated environment.
  • Experience of working within a GMP manufacturing or GLP environment would be beneficial.
  • Experience with documentation such as SOPs, Deviations, Risk Assessments, Technical Protocols and Reports.
  • Competency in Microsoft Office.
  • Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage.

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.

No agencies please

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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