Quality Compliance Stability Specialist

  • Location: Waterford, hybrid

About the job

You will work with a team of highly trained QC specialists to support the overall QC department in matters related to stability and compliance. You will take ownership for the planning and management of stability programs, preparing and analysing trend data and ensuring the QC laboratories are maintained in an Always Audit Ready state.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

  • Management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders

  • Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs) Raising and on time closure of Stability, PQR and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs

  • Ensure effective co-ordination and support for external and internal audits for the department

  • Perform critical / constructive review of Stability, PQR and trending related procedures and practices

  • Identify and lead projects to make step change improvements to the department’s Quality

About you

  • Experience in stability

  • Knowledge of cGMP and GDP in a regulated environment

  • Working knowledge of quality systems in a regulated environment

  • Excellent accuracy and attention to detail

  • Excellent interpersonal skills

  • Continuous improvement techniques

  • Bachelor's Degree in Science/ Engineering or equivalent

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

  • Play an instrumental part in creating best practice within our manufacturing facility

  • Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym

Pursue Progress . Discover Extraordinary .

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !