At a Glance
- Tasks: Ensure quality and safety of pharmaceutical products, leading improvement initiatives and mentoring QA specialists.
- Company: Join Sanofi, an innovative biopharma company transforming lives with cutting-edge technology.
- Benefits: Flexible working pattern, professional development, and a chance to shape the future of medicine.
- Other info: Be part of groundbreaking projects and enjoy a supportive, inclusive workplace.
- Why this job: Make a real impact on global health by ensuring safe and effective treatments reach patients.
- Qualifications: Must be a Qualified Person with experience in sterile product manufacturing and strong communication skills.
The predicted salary is between 56700 - 69300 £ per year.
Location: Waterford, Ireland
Working Pattern: 3 days onsite, 2 days remote per week
As Qualified Person within our Quality Lyo APU team, you'll play a critical role in ensuring that sterile pharmaceutical products are manufactured and released in full compliance with cGMP regulations. Reporting directly to the Head of Quality Lyo APU, you'll provide expert oversight of quality systems, lead improvement initiatives, mentor QA specialists, and ensure timely batch certification and release. This is an opportunity to be instrumental in shaping best practices at our award-winning Waterford site as we continue to grow and expand our capabilities.
Main Responsibilities:
- Make sure all products released from the site meet strict quality and safety standards before they reach patients.
- Review and sign off on quality documents to confirm everything meets required standards.
- Work closely with other teams to resolve quality issues and close out actions in a timely manner.
- Investigate any product issues thoroughly, making sure they're fully resolved before a product is released.
- Follow all safety procedures carefully and speak up if you notice any safety concerns.
- Lead projects aimed at improving how quality processes work across the site.
- Support and guide quality team members, helping them grow their skills and expertise.
About You:
- You've worked as a Qualified Person, certifying and releasing batches on a manufacturing license — ideally within sterile product manufacturing.
- You're familiar with current regulatory requirements for sterile manufacturing, including Annex 1, and you stay up to date through ongoing professional development.
- You're a strong communicator who can influence others across teams and are genuinely results-driven, following through until quality outcomes are achieved.
- You hold a Master's degree or Pharmacy qualification that meets the eligibility criteria for Qualified Person status (Ireland-based qualification or UK equivalent).
- You're fluent in English.
- You're comfortable working on-site with flexible days based on production schedules, and you're based in Ireland.
Why Choose Us:
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
- Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
- Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.
- Be part of world-first initiatives like our Modulus factory, smart factories, and AI-driven supply chain solutions.
- Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
- Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.
Batch Release Lead Qualified Person in Preston employer: Sanofi EU
Sanofi Waterford is an exceptional employer, offering a dynamic and supportive environment for MSAT Graduates to thrive. With a strong commitment to employee wellbeing, the company provides flexible working arrangements, access to an onsite gym and medical centre, and numerous opportunities for professional growth through structured training and mentorship. The collaborative work culture fosters innovation and teamwork, making it an ideal place for graduates to launch their careers in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Batch Release Lead Qualified Person in Preston
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Sanofi EU. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Sanofi EU.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Sanofi EU. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Sanofi EU is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Batch Release Lead Qualified Person in Preston
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Sanofi EU!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Sanofi EU that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Sanofi EU!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Sanofi EU, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Sanofi EU
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Sanofi EU that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Sanofi EU’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
