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For Companies At a Glance
- Tasks: Lead risk-based audits of suppliers, ensuring compliance with global regulations.
- Company: Join ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Enjoy flexible working, competitive pay, and a focus on your well-being.
- Why this job: Make a real impact on patient lives through high-quality manufacturing standards.
- Qualifications: Degree in Chemistry, Pharmacy, or Microbiology; experience in Quality Audits required.
- Other info: Collaborative culture with opportunities for growth and recognition.
The predicted salary is between 48000 - 72000 £ per year.
Location: London (Hybrid – 2 days per week on-site, with regular European travel)
About the Role
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.
Knowledge, Skills & Experience
- Working experience in a similar Quality Audit role within the pharmaceutical industry.
- 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. That’s why we are committed to creating an environment where every individual can thrive, contribute, and grow. Here’s what makes ADVANZ PHARMA an exceptional place to build your career:
A Culture of Empowerment and Belonging
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.
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
- Long Service Award
89% of employees in our Q1 2024 engagement survey would recommend ADVANZ PHARMA as a great place to work. Apply now, and be part of a team where your growth drives our success!
Please include a CV and Cover letter.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Accounting/Auditing and Quality Assurance
Industries: Pharmaceutical Manufacturing and Hospitals and Health Care
Senior Specialist QA Supplier Auditor – Sterile Manufacturing in London employer: ADVANZ PHARMA
Contact Detail:
ADVANZ PHARMA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist QA Supplier Auditor – Sterile Manufacturing in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who have experience with supplier audits. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU GMP and GDP regulations. Be ready to discuss how you've applied these in past roles, especially in risk-based audits. Show them you know your stuff!
✨Tip Number 3
Don’t just wait for job alerts—be proactive! Regularly check our website for new openings and apply directly. This shows your enthusiasm and commitment to joining ADVANZ PHARMA.
✨Tip Number 4
Follow up after interviews with a thank-you email. Mention something specific from your conversation to remind them of your fit for the role. It’s a small gesture that can make a big impact!
We think you need these skills to ace Senior Specialist QA Supplier Auditor – Sterile Manufacturing in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in quality audits, especially in sterile manufacturing. We want to see how your skills align with the role, so don’t be shy about showcasing your achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how you can contribute to our mission at ADVANZ PHARMA. Keep it engaging and personal.
Showcase Your Audit Experience: Since on-site supplier audits are a must, make sure to detail your audit experiences clearly. Highlight any specific challenges you faced and how you overcame them, as this shows your problem-solving skills.
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’s super easy!
How to prepare for a job interview at ADVANZ PHARMA
✨Know Your Regulations
Make sure you brush up on EU GMP and EU GDP regulations before the interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you understand their implications for quality audits.
✨Showcase Your Audit Experience
Prepare specific examples from your past experiences where you conducted supplier audits, especially in sterile manufacturing. 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 Collaboration Skills
Since this role involves working closely with various teams, be ready to discuss how you’ve successfully collaborated with others in previous roles. Share examples of how you’ve built relationships with stakeholders and contributed to a team-oriented environment.
✨Prepare Questions
Have a few thoughtful questions ready to ask at the end of your interview. This could be about the company culture, the audit processes they use, or how they support professional development. It shows your genuine interest in the role and the company.
