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For Companies At a Glance
- Tasks: Manage training systems and ensure compliance with GMP guidelines.
- Company: Join Oxford Biomedica, a leader in cell and gene therapy innovation.
- Benefits: Enjoy competitive rewards, wellbeing programmes, and development opportunities.
- Why this job: Be part of a mission-driven team making a real impact in healthcare.
- Qualifications: A Level or National Certificate in Science; knowledge of GMP compliance is essential.
- Other info: Experience with Python coding and Veeva Vault is a plus.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Join Us in Changing Lives
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 .
We are currently recruiting for a Quality Systems Officer , responsible for maintaining the Quality Management Systems and promoting continuous improvements to meet the business needs.
Your responsibilities in this role would be:
- Provide primary Quality Systems support for materials, suppliers and services providers
- Maintain supplier and internal audit schedules
- Provide Quality Systems input to annual Quality Reports
- Facilitate updates into Quality/Technical Agreements
- Review Deviations, CAPAs, Change Controls and Supplier Complaints
- Review Computer Systems Validation (CSV) documents
- Identify and lead QMS improvements
- Monitor and produce metrics for GMP compliance
- Deliver training on QMS
Qualifications
- A-Level education in (science preferred) or equivalent experience
- Experience working within a GMP-regulated environment
- Knowledge of pharmaceutical regulations and compliance requirements
- Experience within Quality within a pharmaceutical’s environment
- Hands-on experience using electronic Quality Management Systems (eQMS) to GMP standards
- An understanding and awareness of Computer Systems Validation (CSV)
- An understanding of Quality audits, investigations, and root cause analysis and change Control Processes
- Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint)
- Proven knowledge and application of GMP and wider pharmaceutical Quality standards
- Awareness of Quality Systems with the ability to support and improve them effectively
About Us
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.
Why Join Us
- Competitive total reward packages
Quality Systems Officer employer: OXB
Contact Detail:
OXB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Systems Officer
✨Tip Number 1
Familiarise yourself with GMP compliance and Quality Systems in the pharmaceutical industry. Understanding these concepts will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those who have experience with training systems. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Brush up on your Python coding skills and get acquainted with Veeva Vault if you haven't already. Highlighting your technical skills can set you apart from other candidates.
✨Tip Number 4
Prepare for potential interview questions related to audits and inspections. Being able to discuss your approach to ensuring compliance and readiness will showcase your expertise and fit for the role.
We think you need these skills to ace Quality Systems Officer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the responsibilities and requirements of the Quality Systems Officer position. Highlight your understanding of GMP compliance and Quality Systems in your application.
Tailor Your CV: Customise your CV to reflect your relevant experience and skills that align with the job. Emphasise your knowledge of GMP compliance, training systems, and any experience with Python coding or Veeva Vault.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your commitment to integrity. Mention specific examples from your past experiences that demonstrate your ability to manage training systems and ensure compliance.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at OXB
✨Showcase Your Integrity
Since the company values integrity highly, be prepared to discuss examples from your past where you demonstrated ethical decision-making. This will resonate well with their core values.
✨Demonstrate Your Knowledge of GMP
Brush up on Good Manufacturing Practice (GMP) guidelines and be ready to explain how they apply to quality systems. Showing a solid understanding of these principles will highlight your suitability for the role.
✨Prepare for Technical Questions
Expect questions related to Quality Management Systems and any experience you have with Python coding or Veeva Vault. Be ready to discuss how you've used these tools in previous roles.
✨Emphasise Communication Skills
Strong verbal and written communication skills are essential for this role. Prepare to provide examples of how you've effectively communicated complex information to different stakeholders in your previous positions.
