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Sr Quality Assurance (QA) Officer, Projects.

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
12 Jan 2021
Closing date
9 Feb 2021

View more

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

Job Details

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 QA Officer to join the Projects team within QA.  The purpose of this role is to provide start up QA support to the qualification and licensing of new sterile fill and finish suites and there provide ongoing QA operational support.

Your responsibilities in this role would be:

  • Oversee quality of GMP operations to ensure adequate and timely release of GMP compliant product.
  • Provide direct quality team support during customer and regulatory audits.
  • Ensures that all manufacturing documentation e.g. BMR’s, reports are reviewed and approved on batch completion, and forwarded to QP for on-time batch release.
  • Review quality systems documentation including Deviations, Change Controls and CAPA’s.
  • Investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions.
  • Review Risk Mitigation documentation, validation documents, FMS and Engineering documents, Lab OOS, SOP’s, and Policies.
  • Supporting quality related customer complaint investigations and trending activities.
  • Monitoring the progress of GMP regulated manufacturing and/or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
  • Provides line clearance checks including pre-batch manufacture or testing walk rounds at appropriate and quality critical stages of the batch manufacturing / testing process.
  • Ensuring the effective communication of key information affecting product release to all relevant parties.

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

  • A level / National Certificate in Life Sciences or equivalent
  • Higher National Certificate or Degree in Life Sciences is desirable.
  • Significant experience working within Pharmaceutical QA including experience of supporting validation and sterile operations.
  • Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including sterile drug product manufacturing.
  • Experience of having worked in an ATMP / Biologics Manufacturing environment preferable.
  • Experience of MHRA and or customer / client inspections.
  • Previous experience of automation is desirable.
  • Computer literate (Word, Excel, MS Office)

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

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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