Sr QA Validation Specialist

Start free →

Or apply yourself on the official page →

About the role

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a   Senior QA Validation Specialist   to join our   Quality Assurance   team. This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide. Where: • Location: Raheen, Limerick • Some travel may be required. What you’ll do: • Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program • Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures • Scheduling, executing, reviewing and approving qualification activities • Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria • Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements • Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions, change controls, SOPs, reports and other documentation • Coordinating with other departments and outside contractors/vendors to complete validation tasks • Managing and driving projects • Supervising, providing direction and assigning work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlines The environment and physical rhythms of this role: • Ability to work independently or as part of a team • Strong knowledge and understanding of the equipment used for QC analysis and operations • Ability to communicate with transparency • Meets commitments on scope and on time • You have strong knowledge of Data Integrity • Ability to prioritize and balance multiple tasks simultaneously • You have project management experience Let’s find out if we’re a fit: • To be considered for this opportunity you must have a BS/BA in Engineering, Chemistry or Life Science and requires at least 5 – 8+ years’ proven experience within the field preferred; may substitute relevant experience for education. • Previous experience as a SME in a highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory audits • Strong background in site change controls, risk management and data integrity initiatives/programs • You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11 Thrive today. Grow tomorrow. #IRELIM #JOBSIEST #LI-Onsite #REGNIEQA #REGNQA Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.   Where necessary, we disclose salary ranges for roles in all countries in which we operate.  T

View the official posting →