Compliance Officer, Process R&D
- Experience Level
Our employees are able to develop their careers in exciting new medical technologies, and so can you.
Oxford Biomedica’s Process R&D team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development. PR&D take processes from the laboratory “bench” scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.
We are currently recruiting for a Compliance Officer to join the team. The purpose of this role is to work alongside the team to ensure the timely reporting of project outcomes and timely investigation into project related issues, ensuring compliance with internal procedures and GMP requirements where applicable.
Your responsibilities in this role would be:
- Carry out and co-ordinate data integrity checking of experimental records, technical reports, presentations and other technical documents.
- Responsible for PR&D Data Integrity checking SOP.
- Organise and facilitate investigations and root cause analysis into process and laboratory deviations.
- Identify and implement effective corrective and preventative actions to identified root causes.
- Conduct regular inspections of the PR&D laboratories.
- Organise and facilitate individual and group training with regard to PR&D SOPs.
- Lead updates to process documentation to capture new learnings and best practices.
- Lead and promote process improvement ideas to increase the department’s efficiency.
- Accountable for own performance in alignment with group objectives and deadlines.
- Work in accordance with the OXB quality management system.
To be successful in this role, you will have the following skills and experience:
- Graduate in a science based subject, and/or experience of working to GMP standard.
- Previous experience in the pharmaceutical industry/relevant in an MHRA/FDA regulated environment.
- Experience of working within a GMP manufacturing or GLP environment would be beneficial.
- Experience with documentation such as SOPs, Deviations, Risk Assessments, Technical Protocols and Reports.
- Competency in Microsoft Office.
- Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage.
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