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- 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.
Job description:
Do you pride yourself on your integrity? We do what’s right for employees, patients, and partners, and so can you.
We are currently recruiting for a Quality Systems Officer to join the Quality Assurance team . The purpose of this role is to oversee the Training System, work with departmental Training Delegates, ensure training compliance, and provide improvements.
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.
Your responsibilities in this role include:
- Management of the current Training System and procedures
- Ensure training system compliance for new starters and leavers
- Monitor and produce GMP compliance training metrics
- Prepare and review QA training folders
- Support and coordinate responses to audits and inspections
- Create and maintain readiness for audits and inspections
- Collaborate with the team to ensure site systems meet GxP and Quality expectations
- Ensure manufacturing and analytics sites follow SOPs to meet health, safety, environmental, and quality standards
- Coordinate training on Quality Management Systems and GMP-related procedures, including updates
Profile description:
We are looking for:
- A Level or National Certificate in a Science discipline
- Higher National Certificate or Degree in a science discipline (desirable)
- In-depth knowledge of GMP compliance in the pharmaceutical industry
- Understanding of Quality Systems to support them effectively
- Strong verbal and written communication skills
- Previous experience with Python coding and Veeva Vault (desirable)
- Proficiency in Word, Excel, PowerPoint, Outlook
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. With over 25 years of experience, we are pioneers in cell and gene therapy, supporting clients from early development to commercialization with robust quality systems, analytical methods, and regulatory expertise.
What’s in it for you:
- Highly competitive total reward packages
- Wellbeing programmes
- Development opportunities
- Supportive colleagues
- Diverse and inclusive environment
- State-of-the-art facilities
Join us:
We collaborate with leading pharmaceutical and biotech companies, providing viral vector development and manufacturing in lentivirus, AAV, and adenoviral vectors. Our capabilities span from early-stage development to commercialization, backed by strong quality and regulatory systems.
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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.
