QA SpecialistLocation: WaterfordAbout the jobAt Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need.Reporting directly to the Quality Assurance Team Leader, as a critical leader for Sanofi, you will play an integral role within the Sterile Operations area, transforming the support provided to these functions.Shift Role 24/7 patternFor 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 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized 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.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 responsibilitiesWe are a highly motivated and committed Team of Quality Assurance specialists conducting a wide portfolio of highly specialised activities to support 24/7 Lyophilisation Operations in Sanofi Waterford. Our team works in a fast-paced organisation delivering solutions for our patients and customer needs.Acts as Quality support for systems / processes providing guidance / feedback on quality issues related to Sterile Manufacturing activitiesQA Specialist to focus on Batch release executionAssist in achieving timely and compliant final product dispositionReview, approve, and support procedures and production/testing records as requiredEnsure compliance with aseptic techniques and sterile manufacturing regulationsPerform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with riskCollaborate with cross-functional teams to support quality initiatives and continuous improvement effortsWork with relevant departments to ensure timely closure of quality actions / findingsConduct duties in a safe manner and report all safety issues or concernsMaintain work area to good housekeeping standardsSupport team in achieving team goals/targetsAttend team meetings as requiredMeasure and report RFT / trend data and work with departments to resolve recurring issuesParticipate in internal supplier and regulatory audits and key quality initiatives as appropriatePerform critical/ constructive review of procedures and practicesSupport deviation investigations ensuring deviations are closed prior to product releaseEnsure compliance to Good Manufacturing Practices (cGMP) at all timesAbout youTo excel in this role, you will need to have:Minimum of 5 years previous experience in sterile manufacturing operations is preferable; in particular strong understanding in the management, manufacture and release of sterile productProven ability to provide quality expertise and support to the QA team and site teamsProven ability to support the delivery of tasks in a highly regulated manufacturing environmentEffective technical knowledge of sterile manufacturing processesStrong knowledge of QA methodologies, tools, and processesExperience with quality oversight in manufacturing operationsExcellent analytical, problem-solving, and decision-making skillsStrong attention to detail and ability to work in a fast-paced environmentExperience with regulatory inspections and audits is a plusEffective technical knowledge of sterile manufacturing processesOperational experience of quality systems in a dynamic manufacturing environmentKnowledge of requirements for cGMP, US and EU regulatory requirementsFull understanding of relevant quality and compliance regulationsEffective facilitatorGood communication skills at organisation, team and individual levelsUnderstands KPI’s for the team and siteExcellent interpersonal skillsExcellent influencing skillsExcellent presentation skillsFlexible approach – comfortable with on-going changeTakes personable responsibility for their actionsGood communicator who is comfortable to work as part of a teamFocused on achieving resultsSelf-starter and able to work under minimum supervision Excellent accuracyStrong attention to detail Working knowledge of computer packagesWhy choose us?Bring the miracles of science to life alongside a supportive, future-focused teamDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationallyEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactTake 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#LI-EURPursue 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!