Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.
Oxford BioMedica is at the forefront of this exciting therapeutic area. Specifically, Oxford BioMedica and its subsidiaries have built a sector leading vector deliver platform (LentiVector™), which the Group leverages to develop products both in-
house and with partners.
Our recent successes are driving significant growth. We employ more than 320 people at our current facilities in Oxford and we are planning for further headcount growth over the coming years to facilitate the increased demand for our technology and manufacturing capacity.
We are also planning expansion to our facilities to accommodate additional partners and support ongoing technology development.
If this is something you want to be a part of we’d love to hear from you.
About the role
We have an exciting opportunity to strengthen our Quality department and we are looking to fill the full time position of QA Officer at Windrush Court, Oxford.
Job purpose :
Ensuring QA regulatory compliance and product quality requirements are met at all times, to facilitate product release in a timely manner, while maintaining a strong QA culture throughout the business providing guidance as required.
Key responsibilities and accountabilities :
Oversees quality of GMP manufacturing practices (i.e. aseptic practices) and / or analytics during manufacturing / testing of Drug substance / product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-
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
Providing indirect quality team support during customer and regulatory audits
Monitoring the progress of GMP regulated manufacturing and / or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
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.
Provides line clearance checks including pre-batch manufacture or testing walk rounds at appropriate and quality critical stages of the batch manufacturing / testing process
Investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions
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 or Senior QA Officer.
Lead and communicate minutes of Interface meetings
Key skills and requirements :
Excellent attention to detail
Experience of conducting quality based audits preferable
Experience in quality investigations and root cause analysis
Understanding and experience of Change Control
Experience of MHRA and or customer / client inspections.
Understanding & experience of GMP and pharmaceutical industry QA requirements.
Experience in document control or records management systems in a regulated environment
Experience of having worked in a Biologics Manufacturing environment preferable
Good interpersonal and communication skills
Good team player, and must also be able to work alone
Good organisational and time management skills
Competent in prioritising workload, a decisive thinker and able to work within agreed timescales
Experience of an Electronic Document Management System to GMP preferable
Person Specification :
Minimum of 3 years’ experience working within Pharmaceutical QA
Working knowledge of GMP & Quality related pharmaceutical regulations & standards
A level or National Certificate in a Science discipline
Higher National Certificate or Degree in science discipline desirable
Computer literate (Word, Excel, MS Office)
Solid working knowledge of Validation and Pharmaceutical Quality Management systems