A Validation Manager is required by Careerwise Recruitment to work for our Limerick based medical device manufacturing client, (12-month contract).
Role of this position
- Key Quality representative in multidisciplinary team to support new production line and process validation projects, ensuring compliance.
- Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
- 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.
- As needed, perform or support non-conformance / CAPA root cause investigations, defining action plans and drives these to completion.
- 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.
- Must be able to function and contribute as part of a team, have excellent communication skills, and contribute to team-based decisions.
Please call Michael O'Connor today for further information on 091-452410 or email email@example.com
CareerWise Recruitment (In Search of Excellence)