Gurpreet Kaur Email & Phone Number

Cincinnati Area, Ky

· Managed 40+ simple and complex projects as short as 4 weeks and as long as 2 years· Responsible for management of national and international projects worth over $15 Million per year· Be accountable for the entire project lifecycle: develop work and associate project plans and ensure theproject remains on track.· Track progress of projects using Microsoft Project/Gantt Charts against timeline milestones.· Proficient in leading project teams across many departments and multiple sites.· Work with internal and external teams to overcome challenges as they occur during project.· Good in acknowledging the hurdles in execution and impact on the overall delivery of the projects by communicating issues with the senior leadership team and finding resolutions.· Manage conflicts and work on alignment between the teams to deliver on time.· Lead internal and external status meetings; capture notes, assign action items and own all necessary follow ups.· Relay clear and specific expectations, timelines, priorities, challenges to key internal and external team members.· Eliminate scope creep by ensuring project remains within the parameters of identified in thescope of work as long it meets the customer’s needs. Otherwise, capture the change in scope inchange order.

· Perform In Process, Finished Product, Impurity profiling, Stability, Raw Material Qualification testing and In-house Standard requalification testing using HPLC, UPLC, LC-MS, NMR, UV, DSC, KF, IR, RAMAN· Performed all the QC test for In Process, Finished Product, stability samples under current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), other lab safety and personnel protection as per FDA and ICH Guidelines· Experience in analytical method development and validation, Process Validation, and Quality control testing of OTC pharmaceuticals and oligonucleotide biopharmaceuticals· Experience in testing Raw material, finished product, stability product analysis and real time support for small molecule and Oligonucleotide production at each step of the way· Perform OQ-PQ on HPLC and familiar with HPLC troubleshooting· Perform cleaning verification of the pilot scale production equipment· Analyze and review QC test data, lab notebooks, prepare reports and update certificate of analysis· Manage QC lab chemical and reagents inventory · Experience writing SOPs, Work Instructions, Test instructions governing laboratory procedure

Contractor For P&G

· Expert in Dissolution testing and profiling using manual and automated dissolution testers with online analysis· Performed method development and validation using Tablet processing workstations (TPW/APW Robotics)· Physical testing for informal stability samples (Water Activity, Hardness, Friability, Dissolution, Disintegration)· Performed HPLC Method development and Validation (Linearity, Precision, Accuracy, Recovery) for in-process, finished and process validation· Performed microscopic studies on extended release PE beads in acid and buffer media.· Hands on experience working with LC-MS, HPLC, UPLC, GC, FTIR (AA, UV, Fluorescence), RAMAN, NMR (2D, COSY), PXRD, Dissolution (both manual and automated), Robotics-Tablet Processing Workstation (TPW/APW) with online analysis, Flow Chemistry systems (AFRICA/ASIA)· Expertise in wet chemistry techniques such as UV-VIS spectrophotometry, Conductivity, Karl Fisher Titration, pH, Water Activity measurement, DSC, Viscosity measurement, Hardness and Friability· Developed, validated and transferred analytical methods to different labs· Proficient in data management systems (NuGenesis, LIMS) and Electronic note booking (ELN)· Performed Cleaning Validation Method Development by HPLC (Linearity, Swab recovery)

Master Of Business Administration - Mba, Business Administration, Management And Operations

Master Of Science (M.S.), Chemistry

Bachelor Of Science, Pharmaceutical Sciences

Evaluated by: Educational Credential Evaluators