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Harshitha Ramesh is listed as Associate II - Regulatory CMC Strategy at Pfizer | Biocon Biologics at Pfizer, a company with 112906 employees, based in Greater Chennai Area, India, India. AeroLeads shows a matched LinkedIn profile for Harshitha Ramesh.
Harshitha Ramesh previously worked as Associate II - Regulatory CMC Strategy at Pfizer and Executive - Operations (Drug Product - Biosimilars) at Biocon Biologics. Harshitha Ramesh holds Biocon-Kgi Certificate Program In Biosciences, Biotechnology from Biocon Academy.
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An enthusiastic, result oriented individual passionate about gaining knowledge and skills in the biopharmaceutical industry, and implementing them to achieve organizational and personal goals. I am currently working as Associate-II, Regulatory CMC Strategy at Pfizer. Previously, I worked as an Executive in Biocon Biologics (Operations-Fill & Finish) where biosimilars are aseptically filled into Vials/Cartridges/Pre-Filled Syringes in a cGMP controlled environment. Skilled in preparation of Technical Documents related to Aseptic Process Simulation, initiation of Deviations/Change Controls using TrackWise software with emphasis on quality management systems and continuous process improvement. Strong, versatile and efficient business development professional exhibiting high levels of adaptability and capable of handling team/individual assignments with ease.
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Greater Chennai Area
*Compilation of high-quality Annual Reports for submission to USFDA as part of Pfizer's Hospital Business Unit (Sterile Injectables) *Peer review of Annual Reports to ensure high-quality CMC submissions to USFDA*Received appreciation from global peers for identification of critical CMC errors and for compilation of high-quality submissions.
Bengaluru, Karnataka, India
*Preparation of Technical documents related to Intervention trending for Aseptic Process Simulation on Liquid vial, Lyo vial, Cartridge and PFS lines. Introduced major changes bringing structure and procedural clarity to the document.* Initiation and implementation of CAPA related to process improvement leading to reduction in frequency and duration of.
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Nancy Lubrecht
Colleague at PfizerNarberth, Pennsylvania, United States, United States
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Hossain El Boukri
Colleague at PfizerPuurs, Flemish Region, Belgium, Belgium
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Pranay Kumar Panda
Colleague at PfizerVisakhapatnam, Andhra Pradesh, India, India
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Mona Dawood
Colleague at PfizerEgypt, Egypt
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Amy Dahler
Colleague at PfizerMemphis, Tennessee, United States, United States
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Seiji Ishihara
Colleague at PfizerYokohama, Kanagawa, Japan, Japan
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Saqib Shahan Shaikh
Colleague at PfizerPakistan, Pakistan
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Nils Thibaut
Colleague at PfizerAntwerp Metropolitan Area, Belgium
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Barbara Dequeant
Colleague at PfizerGreater Bordeaux Metropolitan Area, France
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Joana Candeias
Colleague at PfizerLisbon, Lisbon, Portugal, Portugal
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Selected to be a part of the program from October 2018 - February 2019. Gained in-depth knowledge about the pharmaceutical industry with.
Activities and Societies: Organizer of Biotechnology symposium - BioVitaliya in 2017.Top 10% of the class batch.
Activities and Societies: Member of Effervescence club (Chemistry club) and Maths club.Overall second in Biology stream.
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Harshitha Ramesh works for Pfizer.
Harshitha Ramesh is listed as Associate II - Regulatory CMC Strategy at Pfizer | Biocon Biologics at Pfizer.
Harshitha Ramesh is based in Greater Chennai Area, India, India while working with Pfizer.
Harshitha Ramesh has worked for Pfizer and Biocon Biologics.
Harshitha Ramesh's colleagues at Pfizer include Nancy Lubrecht, Hossain El Boukri, Pranay Kumar Panda, Mona Dawood, and Amy Dahler.
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Harshitha Ramesh holds Biocon-Kgi Certificate Program In Biosciences, Biotechnology from Biocon Academy.
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