+ _Location: Waterford_ - _Onsite_ + _Job type: 23-month FTC_ + “This is a day position with time initially on 24/7 shift” **_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_** **_Our Team:_** _We 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._ **_Main responsibilities:_** _Indicate here the main job responsibilities with bullets points, avoiding Sanofi corporate jargon, acronyms, and gender-coded words (you can check if your language is neutral on this_ site (http://gender-decoder.katmatfield.com/) _)_ + Acts as Quality support for systems/processes providing guidance/feedback on quality issues + QA Specialist to focus on Batch release execution + Assist in achieving timely and compliant final product disposition. + Review, approve, and support procedures and production/testing records as required. + Ensure compliance with aseptic techniques and sterile manufacturing regulations + Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with risk + Collaborate with cross-functional teams to support quality initiatives and continuous improvement efforts. + Work with relevant departments to ensure timely closure of quality actions / findings + Conduct duties in a safe manner and report all safety issues or concerns + Maintain work area to good housekeeping standards + Support team in achieving team goals/targets + Attend team meetings as required + 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 deviation investigations ensuring deviations are closed prior to product release + Ensure compliance to Good Manufacturing Practices (cGMP) at all times **Experience** : + Minimum of 5 years of experience working in a pharmaceutical or biotechnological organization + Minimum of 2 years leader experience working in a cGMP in a regulated environment + Strong knowledge of QA methodologies, tools, and processes. + Experience with quality oversight in manufacturing operations. + Excellent analytical, problem-solving, and decision-making skills. + Strong attention to detail and ability to work in a fast-paced environment. + Experience with regulatory inspections and audits is a plus. **Soft skills:** + Excellent interpersonal skills + Excellent influencing skills + Excellent presentation skills + Flexible approach – comfortable with on-going change + Takes personable responsibility for their actions + Good communicator who is comfortable to work as part of a team + Focused on achieving results + Self-starter and able to work under minimum supervision **Technical skills:** + Excellent accuracy + Strong attention to detail + Working knowledge of computer packages **Education:** + Third Level qualification (Bachelor’s degree in Life Sciences or related discipline preferred ) **Languages:** Fluent English **_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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **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, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)