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As a highly skilled Process and Systems Optimization Specialist, you will play a key role in driving quality and process excellence within our organization.
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- Collaborate with cross-functional teams to provide R&D Quality support to Affiliate Medical teams, ensuring seamless communication and execution of quality initiatives.","
- Review, monitor, and approve controlled process documents for quality, compliance, and commitment gaps, utilizing your expertise to identify areas for improvement.","
- Lead investigations and assist in Root Cause Analysis of Quality Issues (QI) and CAPA, applying your analytical skills to drive resolution and prevent recurrence.","
- Support audits and inspections, including pre-inspection support, inspection readiness training, and post-inspection support, ensuring our team is prepared and compliant at all times.">
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- Collaborate with initiative leads and management to prepare, organize, coordinate, document, and provide the development and delivery of department products and services, leveraging your project management skills to drive results.","
- Develop varied support materials, presentations, and tools to support department strategies, applying your creative thinking to communicate complex ideas effectively.","
- Lead small to medium-scale process improvement initiatives, applying your problem-solving skills to drive sustainable change and continuous improvement.">
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- Bachelor's degree in Life Sciences or Engineering, with a strong foundation in scientific principles and methodologies.","
- Minimum 2 years of experience in CAPA management and Quality Audit/Inspection support activities, with a proven track record of delivering quality results.","
- Fluent in English, with excellent verbal and written communication skills, as well as strong interpersonal and collaboration skills.","
- Experience in TrackWise or other electronic Quality Management Systems (eQMS), with a strong understanding of quality management principles and practices.">
This is a fully qualified, career-oriented, journey-level position requiring a thorough understanding of procedural documents, process improvement fundamentals, and clinical management technology and systems, with opportunities for growth and advancement.
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