At a Glance
- Tasks: Conduct audits to ensure compliance and quality in manufacturing processes.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Collaborative culture with opportunities for travel and professional growth.
- Why this job: Make a real impact on global health by ensuring product quality.
- Qualifications: Degree in biological science and experience in GMP environments required.
The predicted salary is between 40000 - 50000 £ per year.
Quality in a globalized supply chain is a matter of operational resilience as much as regulatory mandate. This role serves as a GMP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of scientific data and compliance with legal and corporate standards. By conducting audits of our external partners and internal facilities, you identify the findings and non-compliance trends that could impact the reliability of our product supply. We are looking for an experienced auditor who can navigate manufacturing environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.
Main Responsibilities
- Audit Execution: Conduct assigned external audits of contract manufacturers (CMOs), vendors, and suppliers, as well as occasional internal self-inspections of manufacturing processes and procedures.
- Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA).
- Trend Analysis: Identify non-compliance trends and systematic risks within the GMP discipline, communicating these findings to line management and functional leads.
- Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions.
- Regulatory Knowledge: Maintain up-to-date knowledge of global GMP regulations and industry trends, identifying new requirements to ensure a high level of quality is maintained internally.
Position Qualifications & Experience
- Academic Background: BS degree in a relevant biological science, science, or related discipline.
- Professional Experience: Quality Assurance experience within a GMP-regulated environment, demonstrating a strong understanding of quality management systems and regulatory frameworks.
- Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the manufacturing discipline.
- Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external suppliers.
- Working knowledge of: 21 CFR Part 210/211 Current Good Manufacturing Practice for drugs, 21 CFR Part 600 Biological products, 21 CFR Part 820 (ISO 13485), EudraLex Volume 4 EU GMP Guidelines, Directive 2001/83/EC.
- Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.
Auditor - GMP employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Auditor - GMP
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your experience as an auditor. We want you to showcase not just your skills but also how you fit into their mission.
✨Tip Number 3
Practice your pitch! Be ready to explain your audit experience and how it relates to GMP regulations. We suggest rehearsing common interview questions so you can confidently highlight your expertise when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Auditor - GMP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Auditor - GMP role. Highlight your relevant experience in quality assurance and audit management, and don’t forget to mention your knowledge of GMP regulations. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality in a globalised supply chain and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills: Since this role involves working with multinational teams and external suppliers, make sure to highlight your excellent interpersonal and negotiation skills. We want to know how you’ve successfully collaborated in the past!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way to ensure your application gets to us directly. Plus, you’ll find all the details you need about the role and our company culture there.
How to prepare for a job interview at CSL Behring
✨Know Your GMP Regulations
Brush up on the latest global GMP regulations and industry trends. Being well-versed in 21 CFR Part 210/211, EudraLex Volume 4, and other relevant guidelines will show that you’re not just familiar with the basics but are also committed to maintaining high-quality standards.
✨Prepare for Audit Scenarios
Think about potential audit scenarios you might face in the role. Prepare examples from your past experiences where you identified non-compliance trends or developed corrective actions. This will demonstrate your practical knowledge and problem-solving skills during the interview.
✨Showcase Your Communication Skills
Since this role involves working with multinational teams and external suppliers, practice articulating your thoughts clearly and confidently. Be ready to discuss how you've effectively communicated findings and recommendations in previous roles, as strong interpersonal skills are key.
✨Emphasise Continuous Improvement
Be prepared to discuss how you’ve contributed to improving standard operating procedures (SOPs) in your previous positions. Highlight any initiatives you’ve led or been part of that focused on compliance and risk management, showcasing your commitment to continuous improvement.