At a Glance
- Tasks: Lead QA activities in clinical research and manufacturing, ensuring compliance and managing the Quality Management System.
- Company: Healx, a pioneering company in the pharma/biotech sector.
- Benefits: Flexible part-time hours, competitive pay, and opportunities for professional growth.
- Other info: Dynamic role with a focus on compliance and stakeholder collaboration.
- Why this job: Join a mission-driven team making a difference in healthcare through quality assurance.
- Qualifications: 7+ years in pharma/biotech with strong knowledge of GCP and GMP regulations.
The predicted salary is between 50000 - 70000 £ per year.
Part-time (60-80%) Senior QA Auditor to lead QA activities across clinical research (GCP) and manufacturing (GMP), ensuring compliance with SOPs and regulations and managing the Quality Management System (QMS).
Key Responsibilities
- Manage QMS, SOPs, change control, deviations and CAPAs.
- Conduct internal and external audits and oversee third-party auditors and vendor qualification.
- Review batch records, investigate OOS results and perform root cause analysis.
- Coordinate with Regulatory Affairs for submissions and inspections (MHRA, FDA, EMA).
Requirements
- At least 7 years' experience in pharma/biotech/CRO with Clinical Operations and QA exposure.
- Bachelor's degree in a life science or related field.
- Deep knowledge of ICH-GCP and GMP regulations.
- Strong analytical, communication and stakeholder management skills.
Senior QA Auditor at Healx in London employer: Rocketlist
Healx is an exceptional employer that prioritises employee growth and development, offering a collaborative work culture where innovation thrives. Located in a vibrant area, we provide flexible working arrangements and a commitment to work-life balance, ensuring our team members can excel both professionally and personally while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Auditor at Healx in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma and biotech sectors. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior QA Auditor role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and GMP regulations. We want you to showcase your expertise and confidence when discussing compliance and quality management systems.
✨Tip Number 3
Don’t forget to highlight your experience with audits and CAPAs during interviews. We need to see how you’ve tackled challenges in the past, so come armed with examples that demonstrate your analytical skills.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see your passion for quality assurance and how you can contribute to our team at Healx.
We think you need these skills to ace Senior QA Auditor at Healx in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in QA and clinical operations. We want to see how your background aligns with the role, so don’t be shy about showcasing your relevant skills and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about the Senior QA Auditor role at Healx and how your experience makes you the perfect fit. Keep it engaging and personal.
Showcase Your Knowledge:Since this role requires deep knowledge of ICH-GCP and GMP regulations, make sure to mention specific examples of how you've applied these in your previous roles. We love seeing candidates who know their stuff!
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 don’t miss out on any important updates from us during the process!
How to prepare for a job interview at Rocketlist
✨Know Your Regulations
Make sure you brush up on ICH-GCP and GMP regulations before the interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge practically in your role.
✨Showcase Your Experience
Prepare specific examples from your 7+ years in pharma/biotech/CRO that highlight your experience with QA activities. Discuss how you've managed QMS, SOPs, and conducted audits, as this will demonstrate your hands-on expertise.
✨Communicate Clearly
Strong communication skills are key for this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex topics like root cause analysis or vendor qualifications. This will help you connect with the interviewers.
✨Engage with Stakeholders
Be ready to talk about how you’ve coordinated with various stakeholders, including Regulatory Affairs. Share examples of how you’ve successfully managed relationships and navigated inspections, as this will highlight your stakeholder management skills.
