Associate - QA API EM - Eli Lilly and Company : Job Details

Documents (MRDs). Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program. Participate in regulatory inspection preparations with C - Ms. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures. Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. Review and approve doc...QA, Associate, Quality Control, Operations, Chemistry, Science, Technology