QC Compliance Specialist (Investigation Lead)

About the jobOur Team in 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 works 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.Main responsibilities:Driving of all Quality Metrics for the departmentForward review of Quality Metrics to ensure no over-duesProcedure effectiveness and simplification and actively contribute to continuous improvement initiativeEnsure effective co-ordination and support for external and internal audits for the department.Perform critical / constructive review of procedures and practices. Identify and lead projects to make step change improvements to the department’s Quality.Conduct duties in a safe manner and report all safety issues or concernsSupport leadership team in achieving goals / tasksActively contribute to continuous improvement initiatives utilising lean methodologies where appropriateLiaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit ReadyMaintain training in critical test activities as required in the laboratoryProvide audit support to the QC team including performing routine and pre-audit walkthroughs, assist SMEs to prepare and coordination of QC requests during auditsReview and update QC procedures and processes to ensure compliance to current and updated requirements and regulationsAbout youExperience: Established background in related QC/QA rolesExperience of stability program management preferableSoft skills: Excellent communication and interpersonal skillsAbility to work effectively in cross-functional teamsAccuracy and attention to detail ​Technical skills:Extensive knowledge of cGMP and GDP in a regulated environment Working knowledge of quality systems in a regulated environment Excellent technical writing skillsContinuous improvement techniquesEducation: Honours Degree in a relevant Science disciplineWhat we offerContract for 23 monthsA generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with usWe have highly subsidised restaurant with free tea and coffeeA newly refurbished gym is available onsite for a small and highly competitive annual membership feeYou will be based in our Waterford site which is accessible from M9Parking available onsiteIf the description fits your experience and has aroused your interest, please apply so we can get in contact with you! 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.Pursue Progress, Discover Extraordinary#LI-EURAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.