Skip to main content

This job has expired

Principal QA Officer

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
24 Sep 2021
Closing date
24 Oct 2021

View more

Discipline
Quality, QA / QC, Quality CSV Engineer
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 (QA) team is responsible for the company’s 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 have a new specialist opportunity to join our QA team to focus on the implementation of new technologies with high levels of automation in GMP manufacturing processes.

Your responsibilities in this role would be:

  • Provides subject matter expertise (SME) in relation to QA compliance to impact the design and implementation of a range of new technologies with a key focus on automated technologies.
  • Collaborate with the MSAT and Manufacturing Departments to introduce new and innovative technologies into the manufacturing processes
  • Collaborate with the Validation Department to develop Validation approaches for projects and review facility / equipment qualification documentation
  • Create strategy documents, technical reports and procedures for new Quality processes involved in projects
  • Lead Quality related risk assessments for projects
  • Review and approve project generated policies and procedures
  • Provide handover training and on-going support for QA Operations
  • Provide Quality Technical SME input to investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions
  • Provide direct quality team support during customer and regulatory audits
  • Review quality systems documentation including Deviations, Change Controls and CAPA’s.

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

  • Educated to degree level in a life sciences subject or possess significant industry experience.
  • Extensive experience and subject matter expertise in the Quality Assurance activities associated with automation or computerised systems
  • Extensive working knowledge of GMP, GAMP & Quality related pharmaceutical regulations & standards
  • Experience of direct interaction with Regulatory Bodies (e.g. MHRA, HPRA, FDA).
  • Expert user of quality risk management tools in ICH Q9
  • Experience of having worked in a sterile Manufacturing environment preferable.
  • Experience of isolator technology or similar barrier technologies desirable
  • Extensive experience in authoring and reviewing the full range of QMS documentation.
  • Excellent spoken English communication skills able to deliver concise information to both internal and external key stakeholders

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.

 


Profile description:

 

 

 

We are a pioneering gene therapy business, and our mission is delivering life-changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

 

 

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it; long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world-leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene-based medicines, both in-house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and change lives.

 


We offer:

 

 

 

We are a pioneering gene therapy business, and our mission is delivering life changing gene therapies to patients. We work together, motivated to make a difference, and so can you.

We are pioneers; no one else does what we do.

Gene therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells. It is transforming medicine as we know it, long term and potentially curative treatments for a wide range of diseases are now possible.

We are at the forefront of this exciting area. We have a strong reputation in gene therapy, with world leading expertise in lentiviral vectors. We have a leading, integrated platform of exclusive technologies to design, develop and bioprocess unique gene based medicines, both in house and with partners.

We drive credible science to realise incredible results.

Whether you’re motivated by the discovery and development of product candidates within Research, or by cutting edge tools and technologies including AI and automation of our contract development and manufacturing organisation, we can offer you a career like no other. We are excited about our future. Join us and 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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert