Senior QA Officer, GMP

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Closing date
21 Sep 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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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, GMP to join the team.  The purpose of this role is to provide QA support to the design, build, commissioning / qualification and licensing for a new vector production and aseptic finishing facility, providing expert QA support for Oxford Biomedica operations.

Your responsibilities in this role would be:

  • To be responsible for monitoring, advising and supporting operations to ensure regulatory compliance and to facilitate product release in a timely manner.
  • 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.
  • Participate in continuous improvement initiatives to enhance working practices and to mitigate quality risks.
  • Supporting Quality based projects working as part of a multidisciplinary team as required.
  • Promoting continuous improvement of the Quality Management System.
  • Ensure that the manufacturing and/or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
  • Ensuring the effective communication of key information affecting product release to all relevant parties.
  • Reports on-going progress with QA activities and Deviations to QA Manager.
  • Lead and communicate minutes of Interface meetings.

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

  • Significant experience working within Pharmaceutical QA including experience of supporting validation and sterile operations. Specifically, in sterile products and aseptic Fill & Finish operations, is essential
  • Experience of MHRA and or customer / client inspections.
  • Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including cleanroom design, classification and environmental control / monitoring.  
  • Experience of having worked in an ATMP / Biologics Manufacturing environment preferable.
  • Previous experience of cleanroom design, build and commissioning preferable.
  • Computer literate (Word, Excel, MS Office)
  • Understanding & experience of GMP and pharmaceutical industry QA requirements

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

About us

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.

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.

Contact Us
  • Windrush Court
  • Transport Way
  • OX4 6LT
  • United Kingdom
  • +44 (0) 1865 783 000
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