Job description:
We want you to feel inspired every day. We’re future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you.
We are currently recruiting for a QA Officer to join the Operations team within QA. The purpose of the role is to provide QA support to the Good Manufacturing Practice (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 is accountable for internal and external audits, quality compliance, and control.
This is a PT9 grade role.
Your responsibilities in this role would be:
1. Oversee quality of GMP testing operations or GMP manufacturing operations to ensure adequate and timely release of GMP compliant product.
2. Ensure that all documentation and quality records are reviewed and approved on batch completion and forwarded to QP for on-time batch release.
3. Review quality systems documentation including Deviations, Change Controls, and CAPA’s and provide QA support to resolve compliance issues.
4. 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 GMP standards.
5. Undertake continuous quality and process improvement for efficient ways of working and to meet current regulations.
6. Liaise with stakeholders, e.g., laboratory/production managers, internal customers to provide appropriate QA support and guidance to ensure compliance with GxP quality standards and any other regulatory standards.
7. Communicate updates on activities to Management to ensure tasks are progressing and completed in a timely manner.
We are looking for:
1. A level or National Certificate in a Science discipline.
2. Higher National Certificate or Degree in a science discipline desirable.
3. Understanding of GMP and pharmaceutical industry QA requirements.
4. Excellent attention to detail.
5. Experience of having worked in an ATMP/Biologics environment preferable.
About Us:
Oxford Biomedica 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.
Oxford Biomedica 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. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialization. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What’s in it for you:
1. Highly competitive total reward packages
2. Wellbeing programmes
3. Development opportunities
4. Welcoming, friendly, supportive colleagues
5. A diverse and inclusive working environment
6. Our values are: Deliver Innovation, Be Inspiring, and Have Integrity
7. State-of-the-art laboratory and manufacturing facilities
Collaborate. Contribute. Change lives
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