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
The function of this position is to provide chemistry support and knowledge to the QC team and to other departments. This position also includes performing QC testing by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.
The chemistry team is highly flexible and provides cross functional support. This role allows opportunity to become highly skilled within the team and gain experience in all areas essential to the running of a microbiology department.
This will be a 24/7 shift role (2 x 12hr days followed by 2 x 12hr nights) or 12/7 shift role (4 x12 hr days). Changes to hours may be a requirement in future including shift hours (nights and weekends). Overtime may be required.
Main responsibilities
• Provide Microbiology support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC Microbiology testing (water sampling, water testing, environmental monitoring, compressed air/nitrogen and more) as required.
• Compliance with cGMP and Standard Operating Procedures and pharmacopeias at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Microbiology representation at cross functional meetings.
• Providing audit support for tours and presentations as required.
• Supporting projects as required.
• Conduct duties in a safe manner and report all safety issues or concerns.
About you
• Bachelors Degree in a Scientific discipline (Biology, Chemistry, Biotechnology, Biochemistry or Food science preferred).
• Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo.
• Understands Key Performance Indicators.
• Knowledge of quality management systems (e.g. Veeva/Qualipso/Trackwise).
• Knowledge of lab management systems (e.g. LUNA).
• Be a motivated, ambitious and goal oriented individual.
• 2-3 years working within a QC department in a Pharmaceutical or GMP facility.
• Experience in Microbiological techniques.
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!
Pursue progress, discover extraordinaryBetter 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, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!