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: Dynamic role with travel opportunities and a commitment to inclusion.
- Why this job: Make a real impact on global health by ensuring product quality.
- Qualifications: BS 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 Seqirus
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises quality and innovation in the healthcare sector. With a strong commitment to employee well-being, inclusion, and professional growth, team members benefit from comprehensive training opportunities and a culture that values diverse perspectives. Located in state-of-the-art facilities, employees are part of a global mission to enhance public health through cutting-edge vaccine development, making their work both meaningful and impactful.
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 all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to walk into that interview room feeling confident and ready to show them why you’re the perfect fit for their team!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to GMP and quality assurance. We suggest doing mock interviews with friends or mentors to get comfortable with articulating your experience and skills.
✨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 are proactive about their job search. So go ahead, hit that apply button and let’s get you started on this exciting journey!
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 any specific GMP regulations you’re familiar with. 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 that showcases your expertise.
Showcase Your Communication Skills:As an auditor, strong communication skills are key. In your application, highlight experiences where you’ve effectively collaborated with teams or stakeholders. This will show us that you can navigate complex environments and drive corrective actions when needed.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there, which can help you tailor your application even further!
How to prepare for a job interview at CSL Seqirus
✨Know Your GMP Regulations
Brush up on the latest global GMP regulations and industry trends. Being well-versed in 21 CFR Part 210/211 and EudraLex Volume 4 will show that you’re not just familiar with the basics, but that you’re 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.
✨Showcase Your Communication Skills
Since this role involves working with multinational teams and external suppliers, practice articulating your thoughts clearly. 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 past roles. Highlight any initiatives you’ve led or been part of that focused on compliance and risk management, showcasing your proactive approach to quality assurance.
