QA Operations Specialist

Sanofi; Munster; On-site; EUR 42,000 - 62,000; Full time

Job summary

Sanofi Waterford in Ireland is seeking a Quality Assurance Specialist to join our GMP-compliant QA team. Based in Waterford, you will review documentation, support investigations, and ensure timely closure of quality actions while promoting continuous improvement.

The role requires a science degree, at least 2 years in a GMP environment, excellent attention to detail, strong interpersonal skills, and proficiency with common computer packages.

Qualifications

• Third level qualification (degree in science or related discipline preferred).
• Minimum of 2 years' experience in a similar role.
• Experience working in a GMP environment is required.
• Very good knowledge of cGMP in a regulated environment.
• Excellent accuracy and attention to detail.
• Excellent interpersonal skills.
• Flexible approach – comfortable with ongoing change.
• Good presentation skills.
• Working knowledge of computer packages.

Responsibilities

• Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues.
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
• Work with relevant departments to ensure timely closure of quality actions / findings.
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues or concerns.
• Maintain work area to good housekeeping standards.
• Ensure attendance at place of work when required.
• Support team in achieving team goals/targets.
• Attend team meetings as required.
• Actively contribute to continuous improvement initiatives.

Skills

Quality Assurance

GMP experience

Attention to detail

Communication skills

Education

Science degree

Tools

Microsoft Office

Job description

Job title: Quality Assurance Specialist - Talent Community

• Location: Waterford, Ireland

About The Opportunity

We're always looking for talented Quality Assurance Specialists to join our Quality Assurance team. Whether you're actively exploring your next move or simply curious about what Sanofi has to offer, we'd love to connect.

Based in Waterford, our Quality Assurance team plays a vital role in ensuring that products are manufactured, stored, and packaged in full accordance with cGMP requirements. As part of the site's quality function, we support the development and delivery of GMP training packages, and participate in the preparation and review of procedures and batch documentation to maintain the highest standards of accuracy and compliance. We conduct audits across all departments in line with agreed schedules, helping to ensure the quality system at Genzyme is effectively implemented and maintained. Through consistent, practical application of cGMP principles, we make sure that everyday practices align with regulatory expectations, every time.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

What You'll Typically Work On

• Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Work with relevant departments to ensure timely closure of quality actions / findings
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues or concerns
• Maintain work area to good housekeeping standards
• Ensure attendance at place of work when required
• Support team in achieving team goals/targets
• Attend team meetings as required
• Actively contribute to continuous improvement initiatives

Compliance Related Tasks

• Measure and report RFT / trend data and work with departments to resolve recurring issues
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
• Perform critical/ constructive review of procedures and practices
• Support investigation of deviations ensuring all product deviations are closed prior to product release
• Ensure compliance to cGMP at all times

What We're Looking For

• Third level qualification (degree in science or related discipline preferred)
• Minimum of 2 years' experience in a similar role
• Experience working in a GMP environment is required
• Very good knowledge of cGMP in a regulated environment
• Excellent accuracy and attention to detail
• Excellent interpersonal skills
• Flexible approach – comfortable with on-going change
• Good presentation skills
• Working knowledge of computer packages

Why join our community?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.