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.