Compliance Analyst/Specialist

Compliance Analyst/Specialist

Full-Time 36000 - 60000 £ / year (est.) No home office possible
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Oxford BioMedica Limited

At a Glance

  • Tasks: Ensure compliance of GMP Equipment & Systems, supporting life-changing therapies.
  • Company: Join OXB, a pioneer in viral vector development and manufacturing.
  • Benefits: Competitive rewards, wellbeing programmes, and career development opportunities.
  • Other info: Collaborative culture with state-of-the-art facilities and growth potential.
  • Why this job: Make a real difference in advancing innovative therapies for patients worldwide.
  • Qualifications: A-Level in science or STEM degree, with GMP experience preferred.

The predicted salary is between 36000 - 60000 £ per year.

OXB is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. 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. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

In this role, you will ensure compliance of GMP Equipment & Systems within the manufacturing department enabling efficient batch delivery against production schedule in line with GMP, safety and environmental requirements, playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

  • Generating and reviewing of periodic Asset documentation including audit trails, Asset Folders, and User Access levels
  • Maintaining access control for manufacturing and ensuring trained personnel and host access to support Validation / Engineering activities
  • Supporting in progressing of Validation Lifecycle documents and activities for assets (URS, DQ, RQ, VRRs, CST etc)
  • Generating and updating of asset documentation e.g. equipment logbooks, SOPs
  • Providing technical support and point of contact for queries / data from internal departments e.g. Validation and support QMS, and Audits and Client requests
  • Liaising with Equipment & Systems vendors to resolve any technical issues that are identified
  • Executing NPI actions which relate to equipment introduction or modification
  • Supporting the implementation and review of HAZOPs
  • Acting as the subject matter expert where required for QMS and supporting/taking ownership of QMS records for equipment and Systems

We are Looking For:

  • A-Level, preferably science based with previous industrial experience
  • Graduate in STEM subject (preferred)
  • Experience working in a GMP environment
  • Experience working with Cell & Gene therapy manufacturing equipment and systems, bioreactors, chromatography, clean rooms etc.
  • Ability to travel across all Oxfordshire sites
  • Willingness to work within Cleanroom environment when required

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 30 years of experience in viral vectors; OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Competitive total reward packages, wellbeing programmes that support your mental and physical health, career development opportunities to help you grow and thrive, supportive, inclusive, and collaborative culture, state-of-the-art labs and manufacturing facilities, a company that lives its values.

Compliance Analyst/Specialist employer: Oxford BioMedica Limited

At OXB, we pride ourselves on being a quality and innovation-led employer that empowers our Compliance Analysts/Specialists to make a meaningful impact in the field of life-changing therapies. Our supportive and inclusive culture fosters collaboration and personal growth, while our state-of-the-art facilities and comprehensive wellbeing programmes ensure that you thrive both professionally and personally. Join us in advancing cutting-edge cell and gene therapy solutions, where your expertise will be valued and your career can flourish.
Oxford BioMedica Limited

Contact Detail:

Oxford BioMedica Limited Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Compliance Analyst/Specialist

✨Tip Number 1

Network like a pro! Reach out to people in the industry, especially those working at OXB or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.

✨Tip Number 2

Prepare for the interview by brushing up on your knowledge of GMP environments and viral vector technologies. We want to see your passion and expertise shine through when discussing your experience with equipment and systems.

✨Tip Number 3

Showcase your problem-solving skills! Be ready to discuss how you've tackled challenges in previous roles, especially related to compliance and quality assurance. Real-life examples will make you stand out.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.

We think you need these skills to ace Compliance Analyst/Specialist

GMP Compliance
Quality Assurance Systems
Analytical Methods
Regulatory Expertise
Validation Lifecycle Management
Technical Support
Documentation Management
Asset Management
Cell & Gene Therapy Manufacturing
Bioreactors
Chromatography
Cleanroom Protocols
HAZOP Review
Communication Skills
Problem-Solving Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Compliance Analyst/Specialist role. Highlight any GMP experience and relevant technical skills, as we want to see how you can contribute to our mission.

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about compliance in the biotech field and how your background aligns with our values at OXB. Keep it engaging and personal!

Showcase Relevant Experience: When detailing your previous roles, focus on your experience with cell and gene therapy manufacturing equipment. We love seeing specific examples of how you've ensured compliance and supported quality assurance in past positions.

Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!

How to prepare for a job interview at Oxford BioMedica Limited

✨Know Your GMP Basics

Make sure you brush up on Good Manufacturing Practices (GMP) before your interview. Understanding the key principles and how they apply to equipment and systems in a manufacturing environment will show that you're serious about compliance and safety.

✨Familiarise Yourself with Viral Vectors

Since OXB focuses on viral vector development, it’s crucial to have a solid grasp of lentivirus, AAV, and adenoviral vectors. Be prepared to discuss your knowledge and any relevant experience you have with these technologies during the interview.

✨Prepare for Technical Questions

Expect technical questions related to validation lifecycle documents and asset documentation. Brush up on your understanding of URS, DQ, RQ, and SOPs, as well as any experience you have with bioreactors and chromatography systems.

✨Show Your Collaborative Spirit

OXB values a supportive and inclusive culture, so be ready to demonstrate your ability to work collaboratively. Share examples from your past experiences where you successfully liaised with internal departments or resolved technical issues with vendors.

Compliance Analyst/Specialist
Oxford BioMedica Limited
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