Job Description
Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends.Supervising the End-To-End qualification process ensuring each piece of equipment fits for the intended use, contribute to 365 inspection readiness program, and follow, foster and implement on daily basis a quality culture and any other company manufacturing standards, policies and procedures.As a Principal QA Validation Specialist, a typical day might include, but is not limited to, the following:Having strong knowledge and understanding of equipment used for QC analysis and operationsExperiencing a strong background and familiar with site change control, risk management and data integrity initiatives/programsPrevious experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal and external regulatory auditsScheduling, executing and reviewing/approving qualification activitiesAssessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteriaInvestigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvementsReviews, edits, and approves deviation notifications, deviation investigations, and corrective actionsReviewing, editing, and approving change controls, SOPs, reports and other documentationCoordinating with other departments or outside contractors/vendors to complete validation tasksCollaborating with functional departments to resolve issuesManaging and driving projects and prepares, reviews, or approves status reportsSupervising, providing direction and assigning work to less experienced full-time employees (e.g. validation specialists) and/or contingent workers to meet goals and deadlinesStaying current with industry trends, regulatory requirement updates, and communicating same to teamPerforming other duties assigned by managementSome travel may be requiredThis role might be for you if:You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11You have strong knowledge of Data IntegrityYou have the ability to prioritize and handle multiple tasks simultaneouslyYou have project management experienceTo be considered for this opportunity you should have BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; may substitute relevant experience for education. #J-18808-Ljbffr