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Compliance Office, Engineering

Employer
Oxford BioMedica (UK) Limited
Location
Oxfordshire
Salary
Competitive
Start date
10 May 2019
Closing date
9 Jun 2019

View more

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

Job Details

As a result of growth we are increasing our manufacturing and development capabilities which include the addition of new sites, equipment, IT systems and processes.   We are therefore able to offer an opportunity to GxP Compliance professional to join the Engineering team.

Oxford Biomedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.

As Engineering compliance professional you will be ensuring ongoing compliance with all quality, regulatory H&S and best practice standards within the Engineering department.

Duties & Responsibilities

  • Ensure adherence to Oxford BioMedica quality systems by managing all activities relating to Deviations, Quality Incidence, Change Controls, and Corrective and Preventive Actions..
  • Lead investigations and implement corrective and preventive actions for engineering related deviations.
  • Keep up to date with all relevant H&S legislation and ensure Engineering systems and personnel remain compliant.
  • Manage contractors to implement improvement projects
  • Update engineering SOPs etc. in line with CAPA requirements.
  • Conduct regular self-inspections within the engineering facilities.
  • Lead, promote and facilitate improvement ideas across all facilities, equipment and utility systems.
  • Work cross-functionally to implement CAPA actions and CI projects.
  • Perform audits of engineering systems and processes to ensure compliance with relevant legislation and regulations.
  • Liaise with Quality department to progress quality documentation.
  • Develop KPI’s for presentation within the department and across a wider company audience.

 The successful candidate for this Process Compliance Officer position will have:

  • Time served apprenticeship in relevant discipline or HNC/HND qualification ideally engineering.
  • Experience of working within a Gape environments such as regulated manufacturing clean rooms
  • Experience with documentation such as SOPs, Deviations, Change Controls Risk Assessments and CAPAs
  • Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage
  • Good knowledge of CI tools such as Lean, Kaizen etc.
  • Competency in Microsoft Office

 

We look forward to receiving your application

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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