Mallika Singh

Background

About Mallika Singh

Several years of software consulting & delivery experience in Pharma R&D IT as Information and Business Analyst, Product Owner, Techno functional SME,Product Manager and Validation CSV Lead. Currently employed with Roche. Worked in Pharma and Bio IT Organizations such GSK, Arthrex, Pfizer, Jubilant Biosys, Institute Of Bioinformatics. SAFe PM-PO certified, Providing Consultancy services to scaled Agile projects as business and technical SME including Requirement Gathering, Creation and Analysis. Data Mapping and Analysis(Source to Target Mappings, Business rules and Transformations), Data governance, Computer System Validation, Regulatory Compliance(21CFRPart11) and GxP. Domain Experience on end to end regulatory submissions ( Veeva Vault), clinical, non clinical, product dossier, labeling, artwork applications. Certified expert on Rational tools. Number of years of experience in using life cycle management, data mapping and governance enterprise tools including hp ALM, JIRA, Codebeamer Retina, Marklogic, Snowflakes, RTC, Erwin Analytix DS. Have publications and patent on requirements, validation and quality in the reputed magazines and organizations.