QA Officer(s)
7 days ago
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 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.
Your responsibilities in this role would be:
- 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 QC laboratories or 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.
Profile description:
We are looking for:
- 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.
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 commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What’s in it for you:
- Highly competitive total reward packages
- Wellbeing programmes
- Development opportunities
- Welcoming, friendly, supportive colleagues
- A diverse and inclusive working environment
- Our values are: Deliver Innovation, Be Inspiring and Have Integrity
- State of the art laboratory and manufacturing facilities
We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.
Collaborate. Contribute. Change lives
We offer:
Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.
Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).
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 commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.
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