Responsible for developing, establishing and maintaining QA procedures related to clinical trials to ensure compliance with applicable regulatory guidelines.
Excellent negotiation skills with external and internal clients. Ability to make decisions independently and proactively. Excellent organizational, planning skills
To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file.
Review clinical trial protocols, visit schedules, enrollment assumptions, country requirements, and other study documentation to determine whether and how Labcorp Smart Supply should be used.
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
Production Line Efficiency, Serialization & Systems, Documentation & Compliance, Team Management. Must have experience in Romaco vial packing machines.
University degree in medicine, science, or equivalent. Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation