QC Compliance Officer IV
2 weeks ago
We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.
We are currently recruiting for a QC Compliance Officer IV to join the Analytical Development and QC (ADQC) Team. The purpose of this role is to ensure timely reporting of analytical data, manage the outsourced QC testing and provide oversight of GMP compliance.
Our AD&QC Team supports the development of products through analytical testing to facilitate manufacturing and process development, ensuring appropriate quality controls and use of analytics. The QC Compliance Officer role is office based.
Your responsibilities in this role would be:
Creation and SME review of GMP documentation (e.g. SOPs, certificates, quality reports, samples submission forms, QC testing documents, sampling plans, etc) Communication with clients, CTOs and other third parties Supporting the group in client and regulatory agency audits Attending audits of CTOs as SME Management of outsourced QC testing Raising and progressing Quality Records (e.g. Deviations, Investigations, Change Controls, CAPAs) within a timely manner Liaising with external parties to support with technical aspects and respond to questions Performing calculations for QC Release assays Management of departmental Quality Records Creating, maintaining and checking LIMS static data Managing implementation and control of QCO processes Be a trainer for the team in QCO procedures To work both independently and alongside members of OXB.
Profile description:
We are looking for:
Educated to degree level within Life Sciences Minimum 5 years experience working within a pharmaceutical regulated environment Understanding of GMP and knowledge of QC testing within a GMP environment Understanding of the Quality Management System and reporting structure Thinking critically and analytically in order to problem solve Computer literate (word, excel, MS Office) Excellent interpersonal and communication skills (written and verbal) Highly organised and motivated with excellent attention to detail
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 A 35-hour working week 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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