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- Tasks: Lead sterility assurance strategy and ensure compliance in innovative pharmaceutical environments.
- Company: Join OXB, a pioneer in viral vector development with over 25 years of experience.
- Benefits: Enjoy competitive rewards, wellbeing programmes, and career development opportunities.
- Why this job: Make a real impact in life-changing therapies and work with cutting-edge technologies.
- Qualifications: BSc in Microbiology or related field; experience in aseptic manufacturing and sterility assurance.
- Other info: Be part of a supportive, inclusive culture in state-of-the-art facilities.
The predicted salary is between 48000 - 72000 ÂŁ per year.
Responsibilities
- Defining, implementing, and overseeing OXB\’s sterility assurance strategy, including facility design, qualification, airflow/HEPA certification, media fills, environmental monitoring, container closure integrity, and cleaning/disinfection.
- Promoting compliance with sterility assurance regulations and best practices across the business.
- Supporting aseptic manufacturing and environmental monitoring for VS and VP operations, including contamination control documentation and aseptic fill guidance.
- Leading or supporting sterility assurance investigations, risk assessments, and validation activities.
- Driving continuous improvement in sterility assurance practices, processes, and systems, including adopting new regulations and technologies.
- Managing sterility assurance audits, inspections, and supplier quality oversight, including aseptic processing CMOs.
Qualifications
- Extensive knowledge of GMP, sterile product manufacture, and pharmaceutical regulations/standards.
- BSc degree in Microbiology or related field (advanced degree preferred).
- Proven skills in influencing people using negotiation and interpersonal skills to drive through project priority tasks to ensure on‑time delivery of milestones.
- Proven experience in aseptic manufacturing environments (cleanrooms, isolators, sterility test isolators).
- Strong technical expertise in sterility assurance, contamination control, and cleanroom standards, with hands‑on implementation experience.
- Experience in sterility assurance validation, product validation, and supplier quality management.
- Ability to interpret worldwide aseptic/sterility regulations into practical, compliant execution.
- Experience interacting with regulatory authorities during inspections.
Company
- 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.
- 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; 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.
- 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: Responsible, Responsive, Resilient, Respect.
Ready to Make a Difference?
- Collaborate. Contribute. Change lives.
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Principal QA Specialist - Sterility Assurance employer: Oxford BioMedica Limited
Contact Detail:
Oxford BioMedica Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal QA Specialist - Sterility Assurance
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching OXB's values and recent projects. Tailor your answers to show how your experience aligns with their mission of delivering life-changing therapies. We want to see your passion shine through!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your responses. Focus on articulating your technical expertise in sterility assurance and how it can benefit OXB.
✨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 are proactive about joining our team.
We think you need these skills to ace Principal QA Specialist - Sterility Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principal QA Specialist role. Highlight your experience in sterility assurance and aseptic manufacturing environments. We want to see how your skills align with our mission at OXB!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about sterility assurance and how you can contribute to our innovative team. Let us know what excites you about working with OXB.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've driven continuous improvement in sterility assurance practices or led successful audits. We love seeing results!
Apply Through Our Website: We encourage you to apply through our website for a smooth application process. It’s the best way for us to receive your application and keep track of all the amazing talent out there. Don’t miss out!
How to prepare for a job interview at Oxford BioMedica Limited
✨Know Your Sterility Assurance Stuff
Make sure you brush up on the latest sterility assurance regulations and best practices. Familiarise yourself with OXB's specific strategies, especially around aseptic manufacturing and environmental monitoring. This will show that you're not just knowledgeable but also genuinely interested in their operations.
✨Showcase Your Experience
Prepare to discuss your hands-on experience in aseptic environments and how you've implemented sterility assurance practices in the past. Use specific examples to illustrate your skills in contamination control and validation activities, as this will help you stand out.
✨Demonstrate Your Interpersonal Skills
Since influencing people is key in this role, think of examples where you've successfully negotiated or collaborated with others to achieve project goals. Highlighting your interpersonal skills can really set you apart from other candidates.
✨Ask Insightful Questions
Prepare thoughtful questions about OXB's current projects or future directions in sterility assurance. This not only shows your enthusiasm for the role but also your commitment to contributing to their mission of delivering life-changing therapies.
