safety and compliance with global regulatory and quality standards
Main responsibilities:
• Provide analytical inputs into the risk/benefit profile assessment of global products, by analyzing pre- and post-marketing data.
• Identify and evaluate new...
by monitoring and analysing qualitydata (e.g. Revinate and LQA results);
• Carry out all other reasonable requests in pursuit of continuous improvement;
• Ensure consistent compliance with operating standards and regulatory requirements...
quality KPIs are met and eTMFs are inspection ready at all times.
Role:
• Global oversight of the eTMFs, ensuring that the study teams are maintaining inspection ready files across all programs.
• Establish KPIs and metrics for documents filed in the...
monitoring and analysing qualitydata (e.g. Revinate and LQA results); Carry out all other reasonable requests in pursuit of continuous improvement; Ensure consistent compliance with operating standards and regulatory requirements; Maintain documents...
methodologies and troubleshoot proactively to ensure timely' high-quality' and cost
• effective execution.
• Support Quality Control in reviewing finished goods against factory standards.
• Data Management &, Reporting
• Maintain the PLM system with up-to-date...
the primary point of contact for clients' providing professional and empathetic first-level support while addressing application' access' and data-related issues. - Logging' prioritizing' and managing support tickets end-to-end in line with SLAs...