QA SpecialistCategory:Quality

• Contract: 23 month FTC
• Location: Waterford
• This position is a days’ position with the training in period on 24/7 rotation which consists of 2 days, 2 nights and 4 days off.

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

Are you looking to work in a positive, stimulating work environment? As a Quality Assurance Specialist, you will play an integral role in providing day to day Quality support to the sterile manufacturing operations. By joining our state-of-the-art operation, as a Quality Assurance Specialist, you will be instrumental to creating best practice; and as the organisation grows, you can too!

This position is a days’ position with the training in period on 24/7 rotation which consists of 2 days, 2 nights and 4 days off.

Main responsibilities:

The Quality Assurance Specialist has a primary role in:

• Working as part of the Quality Assurance team on site ensuring products are manufactured, in accordance with cGMP
• To ensure that all work carried out is in compliance with the required standards conforming to company, cGMPs, cGLPs, SOPs, regulatory regulations and guidelines
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Participate in the preparation and review of procedures and batch documentation
• Review and approval of deviation, CAPA’s, quality events, change controls and tasks
• Acts as Quality Point person for processes providing guidance / feedback on quality issues
• 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

About you

• Bachelor’s degree in a science or related discipline is essential
• Previous experience in a manufacturing environment, sterile experience is preferable
• Previous experience in a quality control laboratory, microbiology would be preferable
• Previous experience of working as a quality team member in the biotechnology sector is an advantage
• Knowledge of regulations and standards affecting biologics and pharmaceutical products
• Good communication skills at organisation, team and individual levels
• Must be able to respond quickly to unplanned events, technical issues and changing needs
• All applicants must be open to shift work

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!

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

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.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com