Validation Lead
CPL
Cork
Title: Validation Lead. Essential Duties and Job Functions. Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports. Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing. Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget. Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work. Reviews protocols, reports and data tables generated by peers and contract personnel. Represents the department on cross-functional project teams. As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections. Knowledge, Experience and Skills. In-depth understanding and application of validation principles, concepts, practices, and standards. Proficient in current Good Manufacturing Practices (GMPs. Extensive working knowledge of equipment and systems. Extensive knowledge of industry practices. Excellent verbal, written, and interpersonal communication skills are required. Demonstrated investigation and report writing skills. Proficient in Microsoft Office applications. Some years of relevant experience and bachelor’s degree in science or related field. Some years of relevant experience and a MS or MBA. Some years of relevant experience and a PhD. This job originally appeared on RecruitIreland.com.
2792 days ago