Posted:-1 days ago|
Platform:
Work from Office
Full Time
• Major
Purpose of the Job: 1. Ensure thecompliance of Qualification and Validation in Quality Management System as percurrent GMP regulation. • PrincipalTasks: - 1. Quality RiskAssessment. 2. QualificationActivities (HVAC, Area, Equipment, Utilities & Misc.). 3. Process Validation / Hold Time Study ofSemi-Finished Goods. 4. CSVValidation. 5. Equipment HoldTime study. 6. Out of Trend. • Responsibilities: 1. Quality Risk Assessment; To coordinate, assessment& perform risk assessment of process, equipment, system etc. along withcross functional team, report compilation, verification of mitigation plan (ifany). 2. Validation &Qualification; Ensure validation & qualification state 24x7 for allprocess, equipment, system, utilities etc. Coordination with cross functionalteam, prepare/review respective documents, execution & monitoring ofvalidation & qualification activities, compilation of report along withsupporting documents, re-validation & qualification as per schedule, recordmanagement. 3. Ensure Hold Time study ofSFG, report compilation, notify any abnormal observation during study, andfollow up with concern department for rectification of abnormal observations,record management. 4. Toreview and update document as per regulatory guidelines. 5. Evaluation of out of trend databased on APR, assessment & Investigation with cross functional department,monitoring for implementation of CAPA 6. Reviewand compliance of annual product review. 7. Review& approval of SOP of quality assurance. 8. Anyother job as and when delegated by Head QA. • SecondaryResponsibilities: 1. CleaningValidation. 2. Cleaning ValidationAssessment Study for New product
Cadila Pharmaceuticals
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