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- Tasks: Support quality assurance in biopharmaceuticals and ensure compliance across innovative projects.
- Company: Leading biopharmaceutical services organisation with a global reputation.
- Benefits: Competitive salary, career development, and the chance to influence quality culture.
- Why this job: Make a real impact in cell and gene therapy while advancing your career.
- Qualifications: Degree in a scientific field and experience in GMP environments.
- Other info: Join a dynamic team focused on innovation and purpose-driven work.
The predicted salary is between 36000 - 60000 £ per year.
We are currently looking for a Quality Assurance Specialist to join a leading biopharmaceutical services organisation based in the South West of the UK. Our client specialises in supporting the manufacture of cell and gene therapies (CGT) and biopharmaceuticals. As a Quality Assurance Specialist, you will play a key role in supporting the Pharmaceutical Quality System (PQS), collaborating across Quality, Production, and QC teams to ensure compliance across a range of innovative and regulated manufacturing projects.
KEY DUTIES AND RESPONSIBILITIES
- Support the Quality Manager and Senior QA Specialists in maintaining oversight of the PQS, including deviation and issue management, change control, validation activities, out-of-specification results, supplier oversight, and self-inspections.
- Complete reviews of production batch records and QC test data.
- Maintain and support the documentation control system, including SOPs, batch records, validation protocols, and QC reports.
- Ensure the timely investigation and closure of deviations, audit findings, and out-of-specification events.
ROLE REQUIREMENTS
- A Degree or higher level in a relevant scientific subject area (Pharmaceutical Chemistry / Quality Assurance / Quality Management).
- Proven experience in GMP functions across QA, QC, or Production.
- Demonstrated experience in GMP-regulated environments, including Quality Management Systems, risk management tools, deviation/CAPA processes, and document control.
- Familiarity with HTA, FDA, and UK/EU regulations, and previous exposure to CDMO or ATMP environments would be advantageous.
WHAT’S IN IT FOR YOU?
You will join a respected and growing organisation with global recognition in CGT and biopharmaceutical manufacturing. As a Quality Assurance Specialist, you will have the opportunity to influence quality culture, support impactful clinical projects, and further develop your career in a highly innovative and purpose-driven environment.
QA Specialist in London employer: Hyper Recruitment Solutions LTD
Contact Detail:
Hyper Recruitment Solutions LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the biopharmaceutical industry, especially those working in QA roles. Attend industry events or webinars to make connections and learn about potential job openings.
✨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 QA and having examples ready that showcase your experience in deviation management and documentation control.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills, especially in cell and gene therapy sectors.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. It’s a great chance to reiterate your interest in the position and highlight how your skills fit their needs.
We think you need these skills to ace QA Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Specialist role. Highlight your experience in GMP functions and any relevant scientific qualifications. We want to see how your background aligns with our needs!
Showcase Relevant Experience: When writing your application, focus on your experience in regulated environments. Mention specific projects or roles where you dealt with Quality Management Systems or deviation processes. This will help us see your fit for the role.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points for key achievements and responsibilities. We appreciate straightforward communication, so make it easy for us to see your strengths!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the Quality Assurance Specialist position. We can’t wait to hear from you!
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Be ready to discuss how you've applied GMP principles in your previous roles, especially in QA or QC environments. This will show that you understand the importance of compliance and quality in biopharmaceuticals.
✨Familiarise Yourself with Regulations
Get to grips with HTA, FDA, and UK/EU regulations before your interview. Being able to talk about these regulations and how they impact quality assurance will demonstrate your expertise and readiness for the role. It’s a great way to show you’re proactive and knowledgeable.
✨Prepare for Scenario Questions
Expect scenario-based questions where you might need to explain how you would handle deviations or out-of-specification results. Think of specific examples from your past experience that highlight your problem-solving skills and ability to work under pressure.
✨Show Your Team Spirit
Collaboration is key in this role, so be prepared to discuss how you've worked with cross-functional teams in the past. Highlight any experiences where you supported production or QC teams, as this will illustrate your ability to contribute positively to the quality culture.