Understand and ensure that the team meets applicable regulatory requirements in drug product manufacturing and testing (21CFR210, 211, 11 and ICH guidelines as well as Eudralex).
March 21, 2020
Provide support with DEA audits both internally and externally to ensure that established procedures are being followed and documented, required reports are being filed, and inventories are reconciled.
May 17, 2020
Review cycle count audits of finished goods inventory, investigate inventory discrepancies and in-transit losses, and report findings to the DEA as necessary.
August 03, 2020
Contributes to improvements in unit testing coverage, design test framework, develop test suites, expand automated testing harness and automate scenarios/cases.
August 12, 2020
Support execution of projects necessary to achieve departmental goals, priorities, operational excellence initiatives and work cross functionally with multiple teams.
August 16, 2020
Lead test automation efforts using Behat and Selenium with Java for large Drupal projects and various microservices.
August 22, 2020
Implement and maintain key elements of ICHQ10 Quality System at Harpoon (Change control, deviations/CAPA, product complaints etc.
August 24, 2020