At a Glance
- Tasks: Lead risk-based audits of suppliers and ensure compliance with global regulations.
- Company: ADVANZ PHARMA, a leader in specialty and rare disease medicines.
- Benefits: Flexible working, comprehensive benefits, and a culture of recognition.
- Why this job: Make a real impact on patient lives through quality assurance in pharmaceuticals.
- Qualifications: Degree in Chemistry, Pharmacy, or Microbiology; auditing qualifications required.
- Other info: Join a collaborative team with opportunities for growth and international travel.
The predicted salary is between 36000 - 60000 ยฃ per year.
Location: London (Hybrid - 2 days per week on-site, with regular international 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.
- General auditing qualification (essential).
- External Lead Auditor qualification (essential).
Knowledge, Skills & Experience
- Working experience in a similar Quality Audit role within the pharmaceutical industry.
- Essential: 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. That's why we are committed to creating an environment where every individual can thrive, contribute, and grow. Hereโs 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.
- Global Benefits: Global recognition program, Employee Assistance program, Birthday leave, Two days Volunteer leave, Four weeks working from anywhere, Compassionate leave, Long Service Award.
But donโt 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.
Apply now, and be part of a team where your growth drives our success!
*Please include a CV and Cover letter.
Senior Quality Auditor - Pharmaceutical / Supplier Audits in London employer: ADVANZ PHARMA
Contact Detail:
ADVANZ PHARMA Recruiting Team
StudySmarter Expert Advice ๐คซ
We think this is how you could land Senior Quality Auditor - Pharmaceutical / Supplier Audits in London
โจTip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality audits. A friendly chat can lead to insider info about job openings or even referrals.
โจTip Number 2
Prepare for interviews by brushing up on your knowledge of EU GMP and EU GDP regulations. Be ready to discuss how your experience aligns with the role, especially your auditing skills in sterile manufacturing.
โจTip Number 3
Showcase your mentoring abilities! If youโve trained or guided team members before, share those experiences during interviews. Itโs a great way to demonstrate your leadership potential.
โจTip Number 4
Donโt forget to apply through our website! Itโs the best way to ensure your application gets noticed. Plus, it shows youโre genuinely interested in joining ADVANZ PHARMA.
We think you need these skills to ace Senior Quality Auditor - Pharmaceutical / Supplier Audits in London
Some tips for your application ๐ซก
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 donโt be shy about showcasing your achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why youโre passionate about quality assurance and how you can contribute to our mission at ADVANZ PHARMA. Keep it engaging and personal!
Showcase Your Qualifications: Donโt forget to mention your auditing qualifications and any relevant certifications. Weโre looking for someone with a strong understanding of EU GMP and GDP, so make sure that shines through in your application.
Apply Through Our Website: We encourage you to apply directly through our website. Itโs the best way to ensure your application gets the attention it deserves. Plus, it shows us youโre serious about joining our team!
How to prepare for a job interview at ADVANZ PHARMA
โจKnow 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 audits.
โจShowcase Your Audit Experience
Prepare specific examples from your past auditing experiences, especially those involving sterile manufacturing facilities. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and ability to thrive under pressure.
โจEmphasise Team Collaboration
Since this role involves working closely with various teams, be ready to discuss how you've successfully collaborated in the past. Share instances where you mentored others or contributed to a team project, showcasing your ability to embody the 'One Team' spirit.
โจAsk Insightful Questions
Prepare thoughtful questions about the company's culture, the audit processes, and how they support employee growth. This not only shows your interest in the role but also helps you gauge if ADVANZ PHARMA is the right fit for you.