Teva Senior Human Factors Engineer 

Ireland 

434683310

We would like to invite applications for the role ofat ourWaterford Site

The role is responsible forleading Human Factors/Usability activities within R&D in accordance with FDA and EU regulatory guidelines and best practice.

• Manage human factors (HF)/Usability and risk management activities associated with combination product development throughout their development cycle.
• Ensure HF processes and procedures are followed according to regulations and best-practice.
• Design and execute formative/validation/comparative use HF studies in accordance with US and EU regulatory guidance.
• Develop user needs, task analyses, cognitive-walk throughs, anthropometric analyses, known use issues, use-related risk assessment and threshold analyses documents.
• Develop intuitive IFUs, labelling artwork and associated language
• Write HF related technical reports, scientific advice and regulatory submission documents
• To deliver Customer Service (both internal and external) through project timelines in accordance with quality standards and cost control.
• Identify areas for improvement and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
• Communicate effectively with immediate Line Manager, colleagues and staff from other functions or sections of the Company.
• To ensure that all work carried out is in compliance with the required standards and analysts trained to conform with company, cGMP, cGLP, Health & Safety, Environmental Guidelines and regulatory requirements
• Participate in the management of projects and where appropriate work cross functionally. Ensure progress is maintained on projects to meet defined project timelines.
• Make comprehensive records of all work and write formal reports. Ensure all appropriate documentation is completed right first time (i.e. correct and in full) in order to achieve Customer Service, GMP and GLP.

Are you….

• Educated to degree level, ideally in a Science/Engineering/Product Design/Psychology related discipline, however we're open to alternative educational backgrounds

Do you have…

• An understanding of Pharmaceutical and Combination Product Development Process

• Experience in Human Factors/Usability Engineering and application of risk management within a highly regulated setting, ideally Pharmaceutical/Combination Products

• Familiarity with US and European Pharmaceutical regulatory guidelines- this would be desirable

• Advanced computer skills

• Technical Report Writing

• Project Management skills

• Strong communication skills

• The ability to work autonomously

• Experience of authoring/ reviewing/ approving internal and external documents eg. protocols, reports, and documents suitable for audits and submissions.

Associate Director, Human Factors Manager, CPD