Job Reference: JO-2010-65408_1602059121
Our leading Cork based Medical Device client is looking for a permanent Lab Technical Manager to join their fast paced manufacturing facility.
This position is responsible for providing Operational and Technical direction in the areas of routine laboratory operations, development of laboratory-related capabilities and identification and implementation of improvement projects to increase lab efficiencies.
Responsible for validation of equipment and test methods.
- Provide Operational and Technical guidance to Laboratory Associates performing routine testing and validation/project work.
- Manage, design, execute and co-ordinate new test methods/technologies, analytical method transfers and equipment/process validations to support the laboratory while maintaining focus on lean principles and continuous improvement.
- Provide technical support and direction to laboratory associates in order to ensure that all equipment and analytical test method validations are done to a high standard and within required time-frame
- Lead the execution of qualification and validation protocols as defined by the validation program in support of multiple projects.
- Actively participate in problem identification and problem solving providing technical input & guidance to Out of Specification (OOS) investigations to identify root causes.
- Lead the evaluation, specification and introduction of new instrument purchases for the laboratory.
- Perform routine/periodic review of system/method & audit trails as required
- Actively participate with lab CAPA implementation.
- Identify and implement improvement projects to increase lab efficiencies.
- Ensure laboratory practices are in compliance with Regulatory Authority, Industry Standards, and Novartis and Divisional requirements.
- Drive preparation and actively participate as an SME in both internal audits and external audits by Notified Bodies and Health Authorities, where necessary.
- Bachelor degree in Science or related discipline
- Five years' experience in a highly regulated laboratory environment with validation and people leadership responsibility
- Must be capable of working both on their own initiative and as part of a flexible team in a demanding, regulated environment.
- Strong scientific and technical background with a detailed knowledge of cGMPs, manufacturing processes, problem solving tools, validation processes and analytical methods.
- Excellent attention to detail and technical writing skills essential.
- Excellent communication (written/verbal) and interpersonal skills
- Strong decision-making abilities.
- Strong knowledge of regulatory Quality System requirements (QSR), ISO standard requirements and applicable industry standards (EN/ISO standards) and FDA regulations
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