Offers “Sanofi”

Expires soon Sanofi

QC Stability and Compliance Team Member

  • Internship
  • County Antrim, United Kingdom
  • Marketing

Job description



Job Title

QC Stability and Compliance Team Member

About the Opportunity

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.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

Key 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 Reviews (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
·  Shift work is not required but additional working hours may be required from time to time

About You

To excel in this role you will need to have:-

Essential requirements:

·  Honours Degree in a relevant Science discipline
·  A minimum of 4 years’ experience 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 Sanofi can offer you

·  Opportunity to join a progressive team and to work with the latest developments in Biological products e.g. mAbs
·  Opportunity to gain experience with a diverse range of analytical equipment
·  Opportunity for progression in a fast paced diverse working environment
·  Progression opportunities as the business continues to grow
·  Competitive salary and bonus package
·  Further education opportunities

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.  

The values we are live by are teamwork, courage, respect and integrity.

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.

Make every future a success.
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