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- Tasks: Ensure product quality and compliance in a dynamic pharmaceutical environment.
- Company: Global leader in innovative medical devices and pharmaceuticals.
- Benefits: Permanent position with competitive salary and shift work flexibility.
- Other info: Collaborative culture with opportunities for continuous improvement and career growth.
- Why this job: Make a real difference in patient care through quality assurance.
- Qualifications: Degree in Pharmacy, Chemistry, or Biology; 2+ years in Quality Systems.
The predicted salary is between 36000 - 60000 £ per year.
BioTalent have partnered with a global pharmaceutical organization specializing in the development, manufacturing, and distribution of innovative diagnostic and therapeutic products used in highly regulated healthcare environments. With operations across multiple international markets, they are committed to delivering safe, high-quality medicines that support critical patient care pathways. The organization operates complex manufacturing facilities and maintains rigorous quality standards to ensure compliance with international regulatory requirements and industry best practices.
The Senior QA Specialist is responsible for maintaining and improving the Quality Management System (QMS) to ensure full compliance with GMP regulations and internal quality standards. This role supports manufacturing, laboratory, and distribution activities, ensuring the highest standards of product quality and patient safety.
- Maintain and oversee Quality Systems (CAPA, deviations, change control, complaints, document control) in compliance with GMP and regulatory requirements.
- Review and approve batch records, validation documentation, protocols, and quality-related reports to ensure product release meets regulatory standards.
- Lead internal audits and support regulatory inspections, ensuring inspection readiness at all times.
- Investigate deviations and quality events, perform root cause analysis, and implement effective corrective and preventive actions.
- Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain to drive continuous improvement and ensure product quality and compliance.
Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, or Biology (required). Minimum of 2 years of experience in Quality Systems within the pharmaceutical industry. Strong knowledge of GMP regulations and quality management systems. Experience in sterile manufacturing or highly regulated production environments is an asset.
Quality Specialist - Medical Devices in Oxford employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist - Medical Devices in Oxford
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and medical device sectors. Attend industry events or webinars, and don’t be shy about connecting on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP regulations and quality management systems. We recommend practising common interview questions related to quality assurance and compliance. Show them you’re not just a fit on paper, but also in person!
✨Tip Number 3
Don’t forget to showcase your experience with CAPA, deviations, and internal audits during interviews. We want to see how you’ve tackled challenges in the past. Use specific examples to demonstrate your problem-solving skills and commitment to quality.
✨Tip Number 4
Apply through our website for the best chance at landing that Quality Specialist role! We make it easy for you to showcase your skills and experience directly to the hiring team. Plus, it shows you’re serious about joining our mission to deliver high-quality medicines.
We think you need these skills to ace Quality Specialist - Medical Devices in Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Specialist role. Highlight your experience with Quality Management Systems and GMP regulations, as these are key for us. Use specific examples that showcase your skills in maintaining compliance and driving quality improvements.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality in the pharmaceutical industry. Mention any relevant experiences that align with our mission of delivering safe, high-quality medicines.
Showcase Your Teamwork Skills: Collaboration is crucial in our work environment. Be sure to mention any cross-functional projects you've been involved in, especially those related to manufacturing or regulatory affairs. We love seeing how you can work with others to drive continuous improvement!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at BioTalent
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practice (GMP) regulations before the interview. Being able to discuss specific examples of how you've applied these standards in your previous roles will show that you're not just familiar with the theory, but that you can implement it effectively.
✨Showcase Your Quality Management Experience
Prepare to talk about your experience with Quality Management Systems (QMS). Highlight any specific systems you've worked with, like CAPA or document control, and be ready to discuss how you've contributed to maintaining compliance and improving quality standards in your past positions.
✨Be Ready for Scenario Questions
Expect scenario-based questions where you'll need to demonstrate your problem-solving skills. Think of a few examples where you've investigated deviations or quality events, performed root cause analysis, and implemented corrective actions. This will help you illustrate your hands-on experience in a practical way.
✨Cross-Functional Collaboration is Key
Since this role involves working with various departments, be prepared to discuss how you've collaborated with teams like Manufacturing, QC, or Regulatory Affairs. Share specific instances where your teamwork led to improvements in product quality or compliance, as this will show your ability to work well in a cross-functional environment.