In this role, you will be responsible for the Quality System Improvement Program implementation including working on deployment team to assess gaps, implementation strategy, implementation execution and update of site documentation / processes as needed.
In this role, the selected candidate will assist with the design and execution of stability programs supporting the development of new products as well as the monitoring of all licensed and in-line products to ensure compliance with established Quality Standards and procedures.
In this role, the candidate will support IRT activities with the execution of general operational tasks, which may be associated with facilities, scheduling, assembly, coordination, delivery, and maintenance of study or program-related information.
In this role, you will be responsible for maintaining compliance with PQS requirements, ensuring efficient, plant based procedures are in place, maintaining a state of inspection readiness and ensuring the site meets or exceeds its internal and external compliance / performance metrics.
In this role, the selected candidate will participate in user acceptance testing (UAT) of new software and the subsequent software releases by providing feedback to IT on user experience, representing a non-technical user audience.
In this role, you will assure quality assurance programs are in place, effective and value added. ; Assure observation and audits are completed, identify trends and issues and formulate strategic training and qualification plans.
In this role, you will maintain an expert level of knowledge related to specialized area of technical expertise or GMP requirements and industry trends as described in applicable worldwide regulations.
In this role, the selected candidate will be responsible for the coordination and ongoing monitoring of QI program objectives, including the delivery of performance improvement projects for service and clinical activities.
In this role, you will be responsible for managing quality assurance activities for the full lifecycle of assigned development projects, from specification through design and realization, until test and maintenance.