Shipra Shanthy

• Assemble data for various types of documents (SOPs, protocols) either operational or quality based and create meaningful information architecture in line with cGMP guidelines
• Design/ prepare templates intended for data capture/compilation, Draft investigation reports (OOS, incident) to highlight key information and present it in a cohesive manner for better comprehension of the reader
• Identify team members good at report writing and guide/mentor/train such team members to produce high quality documentation.
• Guide FTOs for alignment with newly published guidelines and share the learning from regulatory deficiency and update other sites periodically
• Support site for preparation of responses of Regulatory, Customer and Internal/GQA audit by substantiating the response with appropriate data.
• Played a key role as a scribe for several audits including FDA, ANVISA etc audit and provided documentation to senior leadership.

Site Program Manager Role

• Driven the Quality Culture Transformation Program in a site with 2500 employees successfully anticipating and mitigating risks in the program whenever required.
• Planed and executed Program interventions, milestones, metrics, and outcomes across site.
• Coordinated activities across 7 pillars: Culture & Communication, Capability Building, Audit Readiness, Procedure vs Practice, Investigations, QC Robustness and LDM & Gemba ( Operation excellence).
• Played a key role in program strategy, project delegation, and program implementation
• Chaired governance meetings on a weekly, monthly, and quarterly basis to present project status and overview at site level for management review
• Executed customer program implementation, spanning 5 departments and 130 users; achieved 100% adoption rate within three months
• Partnered with key stake holders to identify and execute cross-functional goals
• Created and maintained project documentation, plans and progress reports

• Experience in analysis of scientific material with speed, comprehension & discernment in a wide range of biomedical & scientific disciplines contributing to the ‘Web of Science’ platform.
• Headed the project ‘Takeda’ which included curating scientific data, documenting and editing the data as per the client requirement. The project also required writing of scientific abstracts for various new scientific technologies, research collaborations and patents pertaining to the pharmaceutical industry and presenting the data in excel format.
• Facilitated several soft skill trainings like Business Communication, Campus to Corporate, Time Management, E-mail etiquette, Corporate etiquette and several Product awareness (Web of Science) sessions as part of Thomson Reuters, Learning and Development initiative ‘iTrain Programme’.
• Worked on Secondment role as Solution Consultant for the product Web of Science (an online subscription-based scientific citation indexing service). The role entailed travelling to different universities across India and giving product demos and conducting training workshops.(IITs, ICMR labs, IIMs, National Universities)

79.1% aggregate for 4 Semesters.

2nd,4th, 1st and 1st rank in the college in the 4 Semesters

71.9% aggregate for the 3 years