- Grade: L3-1
- Hiring Manager: Philomena Kavanagh
- Location: Waterford
- Job type: Permanent
For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.
About the job
The Quality Assurance Pre-Filled Syringe team is made up of QP’s, Managers, Technical Leads, Team Leads and Quality Specialists, all of whom are dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options to millions of people globally. Being part of this team will allow you to work in a state-of-the-art sterile syringe filling facility. We produce both commercial and clinical products, with a very robust pipeline. It is because of this we are looking for more quality professionals to join our expanding team.
The Qualified Person is responsible to ensure that licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
- Manage the batch disposition process to ensure timely release of product
- Ensure the batch disposition process maintains compliance with site practices & regulatory requirements
- Support major investigations, ensuring all product deviations are closed prior to batch release
- Participate in cross functional teams as Quality/Qualified Person representative
- Provide additional QP support to quality related issues, as the need arises
- Participate on internal committees/teams, as required
- Provide advice and direction to other departments on quality issues
- Ensure independence of the QP on decisions on quality related matters
- Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements
- Provide audit support as required for internal auditing program and supplier audits
- Ideally 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer’s/Importer’s Authorisation (MIA) ; consideration will be given to other relevant experience and education
- Proven leadership skills comparable to 2+ years of management responsibility
- Post Graduate Qualification required (MSc or equivalent)
- Biologics manufacturing experience highly desirable
- Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable
- Training/mentoring experience
- Problem solving, risk assessment and impact analysis abilities
Pursue progress, discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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