Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Manage QMS activities: Change Control, Deviation, CAPA, OOS, OOT, Lab Events.
Conduct Risk Assessments, SOP reviews, and assist in grievance handling.Document & review: Specifications, SOPs, Test Data Sheets, Analytical Test Reports, and Master documents.Review Method Validation Protocols & Reports.Monitor calibration and preventive maintenance schedules.Initiate procurement of impurity/reference standards, chemicals, reagents, columns, and laboratory glassware.Develop and implement site policies and procedures ensuring regulatory compliance.Supervise deviation and CAPA review, approval, and implementation.Create QC goals, objectives, and metrics to drive continuous improvement.Ensure data integrity systems are in place with frequent checks and challenge tests.Lead root cause investigations.Prepare experimental plans during investigations.Implement CAPA parameters post-investigation.Verify CAPA effectiveness.
Acme Generics
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