Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Waterford

Description

Job Title
Quality Assurance Specialist

About the Opportunity
Reporting directly to the Quality Assurance Team Leader, you will play an integral role in providing day to day Quality and compliance support to the Auto-injector Assembly and Packaging area transforming the support provided to this function.

About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is 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
The Quality Assurance Specialist has a primary role in

- Working as part of the Quality Assurance team on site assuring products are manufactured, packaged and stored in accordance with cGMP
- Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to Auto-injector Assembly & Packaging
- Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
- Provide Quality support for projects and technical transfers in the Auto-injector area
- Work with relevant departments to ensure timely closure of quality actions / findings
- Actively contribute to continuous improvement initiatives


Compliance Related Tasks
Ensure compliance to cGMP at all times

About You
To excel in this role you will need to have:- Essential requirements :

- Third Level Qualification (degree in Science or related discipline preferred)
- Previous experience in a Quality Assurance role in a Pharmaceutical environment
- Knowledge of Quality and cGMP in a Pharmaceutical environment
- Experienced in providing quality expertise & support to the QA team and manufacturing. Operational experience of quality systems (e.g. Change Control, Deviation Management, CAPA)
- Ability to support the batch release process in a dynamic environment, ensuring delivery to timelines consistently
- Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
- Excellent accuracy and attention to detail
- Good communication skills at organisation, team and individual levels


It would be advantageous to have (not essential):

- Experience in a Pharmaceutical Packaging Environment (e.g. Line clearance, Material reconciliation, Packaging specifications)
- Experienced in Packaging validation / Technical transfer processes / New product introduction


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
- 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
- Parking available onsite
- 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.

#LI-EUR

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.

About the company

NeuvooBulkIE

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