Smita K. - Application Analyst / Data Migration Expert

Smita K.

Application Analyst / Data Migration Expert

India | Asia/Kolkata (USD)

$19/hr
Full-time : 30+ hrs/week
0, Followers

ABOUT ME

Smita is an experienced professional with Risk Advisory Practice. She is a dynamic individual with over 8 years of experience in IT/Pharma Consulting including Validation Testing, Quality management, Data Migration, Data Analysis, Business Application Analysis, Implementation and Hypercare Support. Worked on CMS, EDMS, QMS and SAP implementation project which includes formalizing system validation procedures, standard operating procedures, SDLC templates, change and incident management procedures, data migration, End User Training for O2C, ILOL and further support.
She has experience in validating end to end (GxP) system such as custom developed ERP, SAP (SD, MM, MDM, MDG), Trackwise, CMS, EDMS applications. Her core competencies include providing validation support for complex data migrations and system integrations across different platforms. Experience with pertinent industry best practices (e.g. GAMP 5) including regulations like 21 CFR Part 11, EU Annexure 11 with major focus on Enterprise systems. Experienced with all the phases of SDLC (System Development Life Cycle) process. Experience in data migration, application implementation & support. Hands-on experience working with the Pharmaceutical organizations to predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures and documentation, GAP assessment, risk analysis to ensure compliance with 21 CFR Part 11 requirements.

SKILLS