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Sterility Assurance Lead

Waterford, Ireland Permanent Date posted 08/07/2024
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Location: Waterford

In line with Sanofi hybrid Working Policy

Job type: Permanent, Full time

About the job

About the Opportunity:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. In this job, as a critical leader for Sanofi, you will play an integral role in providing Quality and compliance support for new exciting projects in the sterile manufacturing operations area.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

  • Oversight of all sterility assurance activities on site
  • Development of sterility assurance and contamination control strategies on site
  • Development of and support for implementation of strategies regarding contamination control, Media Fill, EM and PQ, decontamination, sterilisation, and dehydrogenation, Management and prevention of sterility breaches, Gowning for classified areas
  • Provide advice and support for significant investigations or projects related to sterility assurance, environmental excursions, or contamination concerns
  • Benchmark best industry practice through networking and attendance at key industry events
  • Participate in audits/inspections/visits, both internal and external focusing on sterility assurance aspects

About you

Experience:

  • Established experience in pharmaceutical industry working in a project or operational support quality and/or manufacturing role
  • Experience in Sterility Assurance Role

Soft and technical

  • Good communication skills at organisation, team and individual levels
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
  • Experience of Aseptic media fill/Process simulation qualification
  • Experience participating in the sterility assurance aspects of internal/external audits
  • Knowledge of requirements for cGMP, US and EU regulatory requirements, full understanding of relevant quality and compliance regulations
  • Extensive microbiology knowledge

Education:

  • Bachelor’s degree in a science related subject is essential (preferably microbiology)

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
  • Play an instrumental part in creating best practice within our manufacturing facility.
  • Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym.

If the description fits your experience and has aroused your interest, please apply so we can get in contact with you!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-EUR

#LI-HYBRI

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Developing
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We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.

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