Rajdeep Poddar

- 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.
- Act as Clinical Process Quality Lead (CPQL) for Technology in Clinical Trials business process and provide Quality consultancy with stakeholders.
- 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 Development 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.
- APAC Regional Lead (2023-24) for ThePlus Ambassador for RDQ function to act as a Quality ambassador and liaise with Development Quality Leadership Team by being voice of the associates.
- Co-led initiatives on Psychological Safety and moderated workshops across multiple Quality functions and trained colleagues in Global Quality to promote Psychological Safety in the organization.

• 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.

• Manages efforts to oversee compliance of computerized system validation across organization
• Oversee the monitoring and maintenance of technology solutions for quality management
• Oversee the in-depth analysis of KPIs and indicators of quality management and operational systems
• Leads team in validation of computerized system in Microsoft Azure cloud environment and in-house data centers
• Act as the Quality Project Manager and oversee Quality for computerized systems for internal and external business stakeholders - Quality Lead for multiple projects across organization and ensures the first-time quality and compliance in deliverables
• Guides the Risk Mitigation activity, in support of efforts to identify, categorize and define associated risks and their mitigation plan to ensure risks are removed
• Leads risk mitigation through to completion
• Leads Change Control Board (CCB) team members, responsible for authorizing or rejecting change requests from a technology quality and validation perspective
• Hands on experience in hosting external sponsor audits and conducting vendor assessment as part of the system life cycle - Supported multiple sponsor audits as a SME for Technology Quality and act as the POC for internal stakeholders to ensure audit observations are remediated effectively and efficiently
• Act as the QM Rep for the Quality Issues and CAPA.

• Requirements gathering (URS/ SRS) and analysis for software development for Life Sciences
• Followed Agile model of SDLC
• Validation master plan, user requirements documentation and establishing traceability amongst the same
• Writing Test Plans, Test cases and Verification Plan
• Writing automated fixtures for testing daily builds - Executing manual and automated test cases and acceptance testing, software validation along with timely regression testing and system testing
• Defect logging and management using MS- Visual Studio 2010 Team Foundation Server (TFS) and version control using Perforce
• Team Lead for Knowledge Process Outsourcing (KPO) project performing market research using paid and free databases, and client co- ordination
• Acted as Executive- International Business Development while performing Market research for international markets in life sciences domain.

• Research Student, in Department, (DBT), Govt Of India sponsored project, ‘‘Characterization of angiogenic factors from peri vitelline fluid of Indian horseshoe crab embryos.” - Hands- on experience on Chorio Allantoic Membrane (CAM)
• Assay using chick embryo and number of molecular biology techniques including extraction of RNA, cDNA synthesis, PCR, primer designing, cloning (transformation, plasmid extraction, ligation, digestion, electrophoresis etc.), protein extraction and estimation, SDS- PAGE.

• Conducted Lectures on Biostatistics, Enzyme kinetics, Industrial Microbiology for graduate and post graduate