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- Tasks: Lead risk-based audits of suppliers and ensure compliance with global regulations.
- Company: Join ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Enjoy competitive salary, flexible working, and comprehensive health benefits.
- Why this job: Make a real impact on patient lives through high-quality manufacturing standards.
- Qualifications: Degree in Chemistry, Pharmacy, or Microbiology; auditing qualifications required.
- Other info: Collaborative culture with opportunities for growth and international travel.
The predicted salary is between 40000 - 45000 £ per year.
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Senior Specialist – Quality Audits. In this role, you will support the lifecycle management of our global vendor and supplier network, ensuring compliance with EU GMP, EU GDP, and other applicable regulatory standards. You will lead risk‐based audits—primarily of sterile manufacturing facilities—while mentoring team members and deputising for the Senior Quality Manager – Supplier Assurance as required. This is a highly collaborative role, working closely with colleagues across Quality, Supply Chain, and Regulatory teams, and offers exceptional exposure to diverse suppliers, products, and global manufacturing operations.
What You'll Do
- Conduct and lead risk‐based audits of vendors and suppliers, with a strong focus on sterile manufacturing sites.
- Monitor and maintain the vendor audit programme, ensuring compliance with EU GMP, EU GDP, and relevant MA requirements.
- Perform risk‐based assessments of audit outcomes and liaise with QPs and senior management on required actions.
- Monitor and maintain internal and external CAPAs.
- Maintain vendor validity within the SAP ERP system.
- Evaluate and interpret global regulations to support audit activities.
- Create, revise, and review QA audit documentation, including checklists, questionnaires, SOPs, and guidance documents.
- Mentor team members and support capability development across the audit function.
- Deputise for the Audit Manager as required.
- Thrive in an entrepreneurial environment, and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of 'One Team' through open, honest, and respectful collaboration across functions.
- Contribute to making ADVANZ PHARMA a desired place to work.
About You
We are looking for a highly motivated Quality professional who is passionate about making a meaningful difference to patients' lives through robust supplier assurance and high-quality manufacturing standards.
Qualifications
- Degree in Chemistry, Pharmacy, Microbiology, or equivalent.
- General auditing qualification (essential).
- External Lead Auditor qualification (essential).
Knowledge, Skills & Experience
- Working experience in a similar Quality Audit role within the pharmaceutical industry.
- Proven experience auditing sterile manufacturing facilities.
- Experience auditing external suppliers such as labs, distributors, and transport partners.
- Strong understanding of EU GMP, EU GDP, and relevant global regulations.
- Experience with CAPA management and risk-based decision making.
- Ability to travel nationally and internationally at least twice per month.
- Strong organisational, time-management, and multitasking skills.
- Excellent written and verbal communication skills, including interacting with senior stakeholders at third‐party suppliers.
- Proven ability to work independently, remain calm under pressure, and manage competing priorities.
- Logical, methodical approach to problem‐solving with strong attention to detail.
- Experience auditing medical devices or biosimilars (desirable).
Why ADVANZ PHARMA?
At ADVANZ PHARMA, we believe that our employees are our greatest asset. We are committed to creating an environment where every individual can thrive, contribute, and grow. We foster a workplace rooted in continuous learning, inclusivity, and collaboration. Every voice matters, and we strive to ensure our employees feel valued, respected, and empowered to make a difference.
Flexibility And Support For Your Wellbeing
Our agile and flexible working arrangements, paired with a comprehensive compensation and benefits package, are designed to support your health, career aspirations, and work‐life balance.
Recognition That Inspires
Through our Rewards and Recognition program, we celebrate the extraordinary contributions of our team members. From outstanding achievements to day‐to‐day excellence, we make appreciation a cornerstone of our culture.
Global Benefits
We are proud to offer a comprehensive global benefits package designed to support the health, well‐being, and professional growth of our employees. Our benefits include competitive compensation, health and wellness programs, opportunities for career development, and a strong focus on work‐life balance.
- Global recognition program
- Employee Assistance program
- Birthday leave
- Two days Volunteer leave
- Four weeks working from anywhere
- Compassionate leave
- Long Service Award
But don’t just take our word for it: 89% of employees in our Q1 2024 engagement survey would recommend ADVANZ PHARMA as a great place to work.
How to Apply
Please include a CV and Cover letter.
Title Senior Quality Auditor - Pharmaceutical / Supplier Audits in London employer: ADVANZ Pharma (formerly Concordia)
Contact Detail:
ADVANZ Pharma (formerly Concordia) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Title Senior Quality Auditor - Pharmaceutical / Supplier Audits in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical industry on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and its values. Show how your experience aligns with their mission, especially in quality assurance and compliance. We want to see your passion shine through!
✨Tip Number 3
Practice common interview questions related to auditing and compliance. Think about specific examples from your past roles that demonstrate your skills and problem-solving abilities. We love a good story!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at ADVANZ PHARMA.
We think you need these skills to ace Title Senior Quality Auditor - Pharmaceutical / Supplier Audits in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality Auditor role. Highlight your relevant experience in auditing, especially in sterile manufacturing, and showcase your understanding of EU GMP and GDP regulations.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the pharmaceutical industry and how your skills align with our values at ADVANZ PHARMA.
Showcase Your Achievements: Don’t just list your responsibilities; highlight your achievements! Use specific examples of how you've improved processes or ensured compliance in previous roles to demonstrate your impact.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of all the amazing candidates like you!
How to prepare for a job interview at ADVANZ Pharma (formerly Concordia)
✨Know Your Regulations
Make sure you brush up on EU GMP and EU GDP regulations before the interview. Being able to discuss these standards confidently will show that you're not just familiar with them, but that you understand their importance in quality auditing.
✨Showcase Your Audit Experience
Prepare specific examples from your past experiences where you've conducted audits, especially in sterile manufacturing facilities. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and ability to work under pressure.
✨Emphasise Team Collaboration
Since this role involves working closely with various teams, be ready to discuss how you've successfully collaborated with others in previous roles. Share instances where your teamwork led to improved outcomes or efficiencies, showcasing your ability to embody the 'One Team' spirit.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's audit processes, team dynamics, and future challenges they foresee in supplier assurance. This not only shows your genuine interest in the role but also gives you a chance to assess if the company culture aligns with your values.
