Job Description

The CAPA Analyst is responsible for designing and rolling out a governance structure for monitoring CAPA data and KPIs. Designing and implementing global, regional and local review boards for effective CAPA governance. Stewarding the governance for inputs to provide strong data insights and outputs that identify risk and systemic trends. Embedding a closed loop process for data flow to ensure early risk detection, subsequent review and decision recorded. Train and mentor CAPA users in all required elements and best practices of CAPA monitoring, data collection, recording decisions and risk escalations. This position will support a team of global SMEs, Quality site leads and CAPA coordinators in the execution of CAPA governance to ensure that actions are executed in compliance with all applicable global regulations and standards to ensure an effective and timely CAPA process. This position will be responsible for the creation and delivery of CAPA training practices, coaching CAPA review board attendees on CAPA data governance of local/regional/global processes to ensure the Global CAPA process is compliant with all applicable Olympus procedures & KPIs, international regulations and standards.

Job Duties

• Responsible and accountable for CAPA Data governance structures locally/regionally/globally execution. This includes collaboration with functional teams, defining structure for inputs and outputs from review boards and recording decisions and ensuring escalations have a closed loop for timely assessment.

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  Responsible to develop and support in delivering training on CAPA governance process and visibility tools.

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  Ensures that the CAPA data governance processes are improved and standardized throughout all Olympus global locations and ensures that CAPA reviews boards are executed to high quality standards and meeting KPIs.

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  Perform and Improves on data quality driving strong analytics and risk trends identification with proposed solutions and ensuring a closed loop data flow process to management at review boards (eg Local / Regional / Global CAPA review boards / QSMR).

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  Support and participate in enhancing Monitoring / Measuring / Analytics in Process controls / NCR / Deviations / Calibration / Audits and additional Feeder systems to CAPA.

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  Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related CAPA activities are completed in a compliant and timely manner.

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  Supports in the development of using visibility tools to ensure standard work for CAPA data governance.

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  All Other Essential Duties as assigned by Management.

Job Requirements

REQUIRED QUALIFICATIONS:

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  Bachelor of Business, Analytics, Science, medical, engineering, or scientific discipline.

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  Minimum of 3 years’ experience in a drug/device manufacturer with demonstrated results in effective governance process design and implementation.

• A knowledge of CAPA process to International Regulations and standards.

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  Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses through collaboration with the business and effectively interact with and influence teams and managers.

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  Demonstrated experience in developing structures for inputs and outputs of data governance.

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  Fluency in Japanese and English.

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  Up to 10% international travel. Working during non-core hours to support global colleagues.

PREFERRED QUALIFICATIONS:

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  Competent understanding of International medical device regulations specific expertise in; Strong analytics driving proactive solutions on CAPA principles.

• Strong written and oral communication for diving results.

• Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired result.

• Competent with Microsoft Office 365 Suite, Visio, Adobe, DocuSign, Agile, Power BI and Windows platforms.