Validation Manager
CPL
Limerick
Validation Manager required for Medical device facilitiy in Limerick. Initially a 12 month contract. Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks. Must be Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities. Ensure correct validation processes application (IQ/OQ/PQ/PPQ) via proactive support, and review and approval of documentation. Investigate and trouble-shoot problems which occur and determine solutions. Ensure that the change control procedures are correctly applied, review and approve project and Quality documentation. Identify critical areas for improvement and prioritize and execute the quality improvements initiatives resulting from this. Identity and implement improvements to validation activities, processes and procedures (e.g. efficiency and compliance improvements. Responsible for inspection readiness of the projects in scope of your work, and act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA); Escalate any quality or compliance issues to senior management. Stays current with industry trends, regulatory requirement updates, and communicating same to team. Requirements: At least 5 years of relevant work experience preferably in high volume, highly automated medical device industry. A relevant Bachelor or Master of Science degree (technical, life science or related. Working knowledge of validation of products/equipment/ processes, computer system validation, statistics, risk management, change control. Knowledge of relevant Medical Device regulations (GMP, MDR, QSR CFR 820, ISO 13485, ISO 14971. Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation & full knowledge of industry practices. This job originally appeared on RecruitIreland.com.
1718 days ago