At a Glance
- Tasks: Lead quality investigations and implement corrective actions to ensure product safety.
- Company: Join Sanofi, a pioneering biopharma company dedicated to improving lives.
- Benefits: Career growth opportunities, inclusive culture, and the chance to make a real impact.
- Other info: Work in a dynamic environment with a focus on continuous improvement.
- Why this job: Be a key player in driving quality and safety in life-changing treatments.
- Qualifications: Experience in quality systems and problem-solving skills are essential.
The predicted salary is between 38250 - 46750 £ per year.
Location: Waterford, Ireland
Job type: Onsite, Days
Contract: 23 month Fixed Term Sanofi contract
About the job
Are you passionate about driving a culture of quality, safety, and continuous improvement? Sanofi is seeking an Investigation Lead to join our PFS (Pre-Filled Syringe) Operations team. In this pivotal role, you will act as a role model for our Quality & Safety culture, leading technical and product quality investigations to identify true root causes and implement effective, sustainable corrective actions.
As the responsible person for investigations within your area, you will bring technical expertise, a "right first time" mindset, and a proactive approach to error prevention — all while representing the shift team in engagements with internal and external stakeholders on product quality and safety matters.
Main responsibilities:
- Lead technical and product quality investigations to identify true root causes and implement preventative and corrective actions that ensure zero repeat occurrences.
- Complete investigations to quality standards within required timeframes, meeting business needs.
- Facilitate cross-functional investigations on shift using Gemba tools and act as SME for the Investigation System and associated tools.
- Conduct proactive data collation, trending and analysis to identify process and system improvement opportunities, ensuring adherence to end-to-end lead times.
- Drive timely closure of deviations, commitments and CAPAs; trend customer complaints to identify effective corrective actions.
- Act as shift team coach and role model in collaboration with the Compliance Excellence Lead to drive a culture of compliance and continuous improvement.
- Ensure resolution of and/or appropriate escalation of significant issues; participate in key decision-making in consultation with relevant stakeholders.
- Provide subject matter expertise and support for systems, technologies and products.
- Understand shift team supply commitments to ensure on-time completion of investigations.
- Work closely with shift and process teams to ensure effective, right-first-time document design.
- Support quality systems operations within assigned area, including conducting and supporting audits (internal, corporate, supplier, customer, regulatory).
- Monitor documentation right-first-time performance trends and implement effective CAPAs to prevent reoccurrence.
About you
- Knowledge of cGMP in a regulated environment.
- Working knowledge of quality systems in a regulated environment.
- Sterile manufacturing experience would be very beneficial.
- System investigation experience.
- Experience in connection to the remediation process.
- Excellent accuracy and attention to detail.
- Excellent interpersonal skills.
- Problem solving skills.
Why choose us?
- Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet.
- Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition.
- Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what’s next.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Quality Investigations Lead in Belfast 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 Quality Investigations Lead in Belfast
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Sanofi EU.
We think you need these skills to ace Quality Investigations Lead in Belfast
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Sanofi EU.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Sanofi EU. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Sanofi EU
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Sanofi EU.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Sanofi EU achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
