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- 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 in Maidenhead employer: CSL Plasma
Contact Detail:
CSL Plasma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Auditor - GMP in Maidenhead
✨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 own. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to GMP and quality assurance. We recommend doing mock interviews with friends or mentors to refine your answers and get comfortable with the format.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can leave a lasting impression. We believe it shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Auditor - GMP in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in GMP and quality assurance. We want to see how your skills match the role, so don’t be shy about showcasing relevant projects or audits you've conducted.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality in the supply chain and how your background makes you the perfect fit for our team at CSL Seqirus.
Showcase Your Audit Experience: Since this role is all about auditing, make sure to detail your audit expertise. Talk about specific audits you've performed, the findings, and how you contributed to corrective actions. We love a good success story!
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 info you need about the role and our company there!
How to prepare for a job interview at CSL Plasma
✨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 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.
✨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, highlighting your interpersonal skills.
✨Emphasise Continuous Improvement
Be prepared to discuss how you’ve contributed to improving standard operating procedures (SOPs) in your past positions. Share specific examples of initiatives you’ve supported that led to better compliance or efficiency, showcasing your commitment to continuous improvement.