Work Flexibility: Hybrid
**Based in Macroom, Cork - Hybrid**
The Senior Specialist, CAPA will be primarily responsible for the oversight of the NC/ CAPA process and procedures, and ensure they are compliant, effective and efficient in dealing with quality issues. The Senior Specialist, CAPA will, through building expertise in problem solving methodology, facilitate proactive and effective resolution of issues.
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Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness along with the review and approval of NC/CAPA documentation changes and extension requests.
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Liaise with relevant functional groups, facilitate and guide teams through all stages of the NC/CAPA process.
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Support and coaching of the NC and CAPA teams regarding the application of NC/CAPA global Stryker ERP system eCAPA.
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As a problem solving methodology expert, leads and guides NC and CAPA teams in the application of problem solving techniques and will promote their use and development, e.g., human error reduction, 4Ds, etc.
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Act as a subject matter expert on all NC/CAPA related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
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Knowledge of all procedures related to one’s own activity and ensuring that relevant company procedures are followed.
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Ensure adequate training is developed, maintained and provided to all users of the NC/CAPA process & systems.
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Manage and monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality and business review forums, liaise with other sites ensure compliance to global requirements and metrics are achieved.
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Prepare, execute and lead the NC/CAPA Review board forums.
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Participate in multi-site and global forums.
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Identify continuous improvement and collaboration opportunities.
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Lead and/or participates in cross-site and global project teams in the areas of NC/ CAPA and quality systems improvement.
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Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third party audit activities.
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Ensure compliance to NC/ CAPA processes and procedures.
Education & Qualifications
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Bachelor’s Degree in Engineering OR Science related discipline (level 8)
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Minimum 2 years’ experience in a Quality/Regulatory Affairs function
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Travel Percentage: 10%
