Quality Assurance

6 days ago


Oxford, United Kingdom Oxford BioMedica Limited Full time

We are currently recruiting for a QA Officers to join either the QA Analytics or QA Operations team within QA. The purpose of the role is to provide QA support for either the Oxford Biomedica's GMP Laboratory testing facilities or GMP Manufacturing facilities. Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP guidelines. The team are accountable for internal and external audits, quality compliance and control. Responsibilities Oversee quality of GMP testing operations or GMP manufacturing operations to ensure adequate and timely release of GMP compliant product. Ensures that all documentation and quality records 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 and to provide QA support to resolve compliance issues. Perform walk rounds/inspections in the GMP manufacturing areas at appropriate and quality critical stages of the testing process to ensure the testing is performed to the GMP standards. To undertake continuous quality and process improvement for efficient way of working and to meet the current regulations. To liaise with stakeholders, e.g., laboratory/ production managers, internal customers to provide appropriate QA support and guidance to ensure compliance with GxP quality standard and any other regulations standards. To communicate updates on activities to the Management to ensure tasks are progressing and completed in timely manners. Qualifications A level or National Certificate in a Science discipline. Higher National Certificate or Degree in science discipline desirable. Understanding of GMP and pharmaceutical industry QA requirements. Excellent attention to detail. Experience of having worked in an ATMP / Biologics environment preferable. At OXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world-and we're looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. Benefits Competitive total reward packages Wellbeing programmes that support your mental and physical health Career development opportunities to help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values: Responsible, Responsive, Resilient, Respect We want you to feel inspired every day. At OXB, we're future-focused and growing fast. We succeed together-through passion, commitment, and teamwork. Ready to Make a Difference? Collaborate. Contribute. Change lives. #J-18808-Ljbffr



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