Offers “Sanofi”

Expires soon Sanofi

Quality Officer

  • Dublin, IRELAND
  • Project / Product management

Job description



Job Title

Quality Officer 

About the Opportunity

·  Contribute to the maintenance of the quality management system of the Irish country office.
·  To ensure the efficient management of product issues and quality complaints.
·  To evaluate the manufacturing site Product Quality Reviews.
·  To implement and maintain technical agreements with manufacturing sites and GXP suppliers.
·  GDP Responsibilities - management of temperature data.
·  To ensure inspection readiness.
·  Reports to Ireland Country Quality Head and Responsible Person.

About Sanofi Quality

The Ireland Quality Department is responsible for the Quality Management System in the Irish country office.  We work across all therapy areas to manage product-quality related issues. We are responsible for all aspects of GXP within the Irish Affiliate and work closely with other departments such as Customer Services, Regulatory Affairs, Pharmacovigilance and Medical Information to ensure the quality of products and services provided to our patients.

Key responsibilities

·  To support the needs of the marketing authorisation holder business in Ireland.
·  Provide strategic input into plans for product development, commercialization and discontinuation.
·  Manage Product Technical Complaints and Medical Device Complaints.
·  Quality Assurance within the Irish Affiliate and Business Units.
·  Perform Risk Assessments for critical processes.
·  Manage GXP-related changes through change control process.
·  Manage deviations and CAPA implementation.
·  Evaluation of Product Quality Reviews.
·  Third Party Supplier Management.
·  Implementing and updating agreements with GXP Suppliers.
·  Good Distribution Practices.
·  Maintain Compliance, Safety & Quality.
·  To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. 

About You

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

Essential requirements:

·  Minimum life science degree.  Previous relevant work experience in quality or pharmaceutical manufacturing.
·  Good understanding and knowledge of GMP and GDP.
·  Excellent attention to detail.
·  Computer skills: Microsoft office package and ability to quickly become familiar with several corporate databases and reporting tools.
·  Good oral and written communication skills.
·  Thorough understanding of HPRA requirements and guidelines, relevant Irish Statutory Instruments and IPHA Codes of Practice.
·  Flexible approach and the ability to adapt quickly to changing priorities.
·  Highly self-motivated and organised with ability to work using own initiative.
·  Excellent interpersonal and communication skills.

What Sanofi can offer you

·  A role where you are instrumental to creating best practice and as the organisation grows, you can too.
·  We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
·  The role is office based in Dublin.
·  This is a full-time role and we support flexible working.

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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