Rajdeep Poddar Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

•Sponsor and provide consultancy on e-technology initiatives aimed at transforming development processes. Review relevant processes and their documentation to establish their applicability for the use of digital technologies.•Support the development of appropriate UATs for study specific builds to ensure technology is fit for purpose based on specific study design.•Facilitate the ‘Quality with Technology’ discussions with GDD business System Owners and other interested parties… Show more •Sponsor and provide consultancy on e-technology initiatives aimed at transforming development processes. Review relevant processes and their documentation to establish their applicability for the use of digital technologies.•Support the development of appropriate UATs for study specific builds to ensure technology is fit for purpose based on specific study design.•Facilitate the ‘Quality with Technology’ discussions with GDD business System Owners and other interested parties to promote greater understanding of quality challenges when working with technology and overcome them through improved collaboration and awareness.•Provide expertise and guidance to business partners in investigations, root cause analysis and risk mitigation assessments of quality incidents and change management process. Assist IT to ensure timely completion of validation aspects of third-party assessments. Show less

Hyderabad Area, India

Ensure implementation of the NBS QA eCompliance strategy and all applicable Novartis and regulatory requirements for GxP regulated computerized systems related to Development IT (DIT) portfolio. Advise strategic projects on validation strategies including novel approaches to quality assurance. Single Point of Contact for all CSV related matters for GxP Global Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified… Show more Ensure implementation of the NBS QA eCompliance strategy and all applicable Novartis and regulatory requirements for GxP regulated computerized systems related to Development IT (DIT) portfolio. Advise strategic projects on validation strategies including novel approaches to quality assurance. Single Point of Contact for all CSV related matters for GxP Global Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. Collaborate with Quality Audit for on-going review of audits related to CSV and Data Integrity (DI) observations. Ensure feedback into QM trigger process for any updates as necessary. Show less

India

Hyderabad, Telangana, India

SME for CSV. Act as the Validation Lead for computerized systems, accountable for validation, consultation, and advice to CSV team. Work closely with Business to maintain validation key deliverables throughout system, product and infrastructure life cycle. Act as an audit representative in and across audits and inspections.

Hyderabad Area, India

SME for CSV and act as the Validation Lead for high risk/complexity systems. Work with the CSV project team for the continued maintenance of validated systems, including Change Control and maintain the system in the validated state throughout the system lifecycleAccountable for establishing key validation deliverables, including validation planning, summary reporting and Electronic Records and Electronic Signature (ER/ES) compliance (e.g. 21 CFR Part 11, Annex 11 and Japan ER/ES)Act… Show more SME for CSV and act as the Validation Lead for high risk/complexity systems. Work with the CSV project team for the continued maintenance of validated systems, including Change Control and maintain the system in the validated state throughout the system lifecycleAccountable for establishing key validation deliverables, including validation planning, summary reporting and Electronic Records and Electronic Signature (ER/ES) compliance (e.g. 21 CFR Part 11, Annex 11 and Japan ER/ES)Act as CAPA Lead, be responsible for root cause analysis of technology quality related incidents Show less

Hyderabad Area, India

Subject Matter Expert (SME) in both CSV and the pharmaceutical industry Accountable for establishing key validation deliverable, including validation planning, summary reporting for medium and high risk/complexity systemsResponsible for root cause analysis of technology quality related incidents (level 2 & 3) for single-project sponsorsResponsible for establishing, reviewing, authorizing and rejecting change requests from a technology quality & validation perspective for low and… Show more Subject Matter Expert (SME) in both CSV and the pharmaceutical industry Accountable for establishing key validation deliverable, including validation planning, summary reporting for medium and high risk/complexity systemsResponsible for root cause analysis of technology quality related incidents (level 2 & 3) for single-project sponsorsResponsible for establishing, reviewing, authorizing and rejecting change requests from a technology quality & validation perspective for low and medium risk/complexity systems Show less

Pune Area, India

Requirement gathering and analysis as a part of SDLCLife Sciences Domain inputs to Software Development Team, Test PlanningTesting the software with respect to Acceptance criteria, Regression testing Inputs on Bioinformatics projects

Pune Area, India

Worked on a research project on Angiogenesis funded by Department of Biotechnology, Government of India

Mumbai Area, India

Theory Lectures and practicals for B.Sc. and M. Sc. in Biostatistics, Enzyme kinetics as well as theoretical coursework for Certificate and Diploma in Molecular BiologyOrganized Seminar on Specialized Aspects of Biotechnology at C. K. Thakur ACS College, New Panvel, Navi Mumbai

Data Science

Six Sigma

Green Belt certification in Six Sigma

Industry Program In Bioinformatics, Bioinformatics

Distance course in Bioinformatics

B.Sc., Microbiology

Activities and Societies: Awarded prizes in Quiz, Seminars, Project and Skit Competitions held at an Intra collegiate and Inter collegiate.