Quality Compliance Stability Specialist​

Job description

Location : Waterford

Job type: 23 month contract

About Waterford

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 QC team at Sanofi Waterford support many diverse manufacturing platforms across the site including Oral Dose, Sterile Injectables and Medical Devices. This diversity ensures that QC team members are presented with opportunities to gain a wide range of knowledge and experience and to grow their careers.

The successful candidate will work with a team of highly trained QC specialists to support the overall QC department in matters related to stability and compliance. They 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.

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 Product Quality Review (PQRs)
·  Management of quality metrics related to deviations, laboratory investigations, CAPAs etc.
·  Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
·  Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g., new or updated pharmacopoeia chapters

About you

·  Honours Degree in a relevant Science discipline
·  Established background in related QC/QA roles
·  Excellent communication skills and ability to work effectively in cross-functional teams
·  Excellent technical writing skills
·  Experience of stability program management preferable
·  Experience in the use of statistical analysis software packages e.g., Minitab an advantage

What we offer

·  Contract for 23 months
·  A generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
·  We have highly subsidised restaurant with free tea and coffee
·  A newly refurbished gym is available onsite for a small and highly competitive annual membership fee
·  You will be based in our Waterford site which is accessible from M9
·  Parking available onsite

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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.