Regional Qualification Expert
Core
Conduct statistical data analysis and validation reporting to ensure compliance with quality regulations for pharmaceutical and medical device qualifications.
Role type
Senior IC data analytics and qualification validation expert
Builds
Qualification reports and statistical analysis for R&D and Manufacturing facilities
Domain
Healthcare / Pharmaceutical / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical methods definition, data interpretation, deviation identification, report writing, Quality Management Systems (QMS), protocol adherence
Preferred skills
Stakeholder management, advanced communication, decision making, proactive problem identification, conflict resolution, presentation skills
Technologies
Veeva, Kneat, Word, Excel, PowerPoint
Responsibilities
Conduct initial data interpretation and verify report accuracy, Define statistical methods for data analysis, Utilize statistical tools to generate data graphs and interpret results, Collaborate with site-specific Subject Matter Experts to review analysis outcomes, Identify and report deviations, Summarize findings and provide clear interpretations of statistical analysis, Ensure all reports comply with global and local quality regulations
Seniority
Mid-Senior, hands-on IC
