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 are currently recruiting for a Senior QA Officer to join the Operations team within QA.  The purpose of the role is to provide expert QA support for Oxford Biomedica Manufacturing Operations.

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 ideally supporting 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

No Agencies please

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.