Quality Systems Officer
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 full-time position of Quality Systems Officer at Windrush Court, Oxford.
Key responsibilities and accountabilities:
- Supports the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/ testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND and site-specific authorisations
- Providing direct quality team support during customer and regulatory audits
- Create and maintain a state of readiness in order to satisfy regulatory and client expectations during audits and inspections
- Work in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
- In depth knowledge of the pharmaceutical industry in terms of regulations and compliance
- Awareness and understanding of Quality Systems in order to support them effectively
- Communicate compliance updates
- Knowledge of the different aspects of the OXB business in order to assist in investigations
- Actively support continuous improvement of Quality Management Systems
Represent Quality in all new projects to ensure quality is built in as early as possible.
- 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 and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.
- Reports on-going progress with QA activities and Deviations to Head of Quality.
- Attend meetings and follow up communications across the Quality Systems team and other departments.
Key skills and requirements:
- 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 Quality Management systems.
How to Apply
Please use a cover letter to highlight how you meet the competencies for the role which will be used along with your CV and questionnaire to assess your application.
Please note that speculative CVs will not be considered.
Closing Date: 14th June 2018
Please note that we may when necessary be required to close a job prior to the closing date, due to a large number of applications or change in circumstance.
*no agencies please*
This job was originally posted as www.totaljobs.com/job/81451554