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 salary, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to improving patient outcomes.
- Why this job: Make a significant impact on quality assurance in innovative healthcare solutions.
- 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 employer: Rocketlist
Healx is an exceptional employer that prioritises employee growth and development, offering a collaborative work culture where innovation thrives. As a part-time Senior QA Auditor, you will enjoy the flexibility of a 60-80% role while contributing to meaningful projects in the pharma/biotech sector, with access to comprehensive training and support to enhance your expertise in quality assurance. Located in a vibrant area, Healx fosters a dynamic environment that encourages professional advancement and values the contributions of every team member.
StudySmarter Expert Advice🤫
We think this is how you could land Senior QA Auditor at Healx
✨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 those interviews by brushing up on your knowledge of ICH-GCP and GMP regulations. We want you to be able to discuss these confidently, showing that you’re the perfect fit for managing QMS and conducting audits.
✨Tip Number 3
Don’t forget to showcase your analytical skills! When discussing your past experiences, highlight specific examples where you’ve successfully managed deviations or conducted root cause analysis. We love seeing those real-world applications!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate candidates who are ready to take on the challenges of QA in clinical research and manufacturing.
We think you need these skills to ace Senior QA Auditor at Healx
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in QA and compliance, especially in GCP and GMP. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about QA in the pharma/biotech space and how your skills can contribute to our team. Keep it engaging and personal – we love to see your personality!
Showcase Your Analytical Skills:Since the role involves root cause analysis and investigations, make sure to mention specific examples where you've successfully tackled complex problems. We’re looking for those strong analytical skills that will help us maintain high standards.
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 at Healx!
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 past roles that highlight your experience in managing QMS, conducting audits, and handling deviations or CAPAs. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Communicate Effectively
Since strong communication skills are key for this role, practice articulating your thoughts clearly and concisely. Be ready to discuss how you've managed stakeholder relationships and coordinated with regulatory affairs in previous positions.
✨Ask Insightful Questions
Prepare thoughtful questions about Healx’s current QA processes and challenges they face. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
