Mabel Rodrigues

QA functions involve a whole lot of Quality systems, Regulatory Affairs, validation activities of the sterile aseptic processes, stability etc. Providing extended help to the Corporate RA for the E-CTD submissions. Handling and Execution of Projects for ANDA’s, NDA’s, EU-CTD, TGA and MCC dossiers. Main Interests revolve around the Sterility Assurance Document and its compilation of Data for the various dossiers. Actively involved in Handling and Participating in Audits since 2005 for USFDA (Twice), MCC, TGA, Slovenia etc and other customer audits. My areas of expertise include Regulatory and Quality systems. Specifically involved in Preparation of Audit compliance Reports. Mastered the ability to organise teams and coach members on the quality activities related to the current GMPs and the various aseptic processes.