Quality And Compliance Specialist
CurrentI review and trend analytical data generated by Analytical Services laboratory and external contract laboratories, including but not limited to products, method validation / verifications, method transfers, stability studies, standard qualifications, Research and Development samples, and third party samples for accuracy, completeness, and compliance to data integrity, written procedures, CGMP regulations, and USP/BP/EP/JP compendia. I am involved in authoring and reviewing certificate of analysis, change controls, methods, protocols and reports for method verification / validation / transfer, stability studies, product characterization, standard qualification, and product-specific technical documents to ensure all analytical executions and methods are in compliance to data integrity, written procedures, CGMP regulations, and USP/BP/EP/JP compendia.I support analysts with technical and scientific guidance for analytical projects and investigation for method, instrumentation and procedural issues and provide technical consultation to inter- and intradepartmental and other Piramal Pharma Solutions facilities.