Please complete the CAPTCHA to continue
A concise factual answer block for searchers comparing this professional profile.
Harshitha Ramesh is listed as Associate II - Regulatory CMC Strategy at Pfizer | Biocon Biologics at Pfizer, a with 112906 employees, based in Greater Chennai Area, 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.
This section adds company-level context without repeating Harshitha Ramesh's masked contact details.
Review company-level records connected to Harshitha Ramesh before choosing the right outreach path.
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.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
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 interventions during aseptic batch filling operations. * Preparation of Protocol for operator qualification for physical inspection of filled Vials & Cartridges. * Checking CAPA effectiveness in the manufacturing facility.* Initiation of Deviations, Change Controls using TrackWise software as part of Quality Management System.* Trained and qualified in visual inspection of media filled units as part of Aseptic Process Simulation (Vials, Cartridges, Pre-Filled Syringes).* Revision of SOP's related to the manufacturing facility.* Prepared SLIA for peristaltic pumps.* Handling of Building Management System (BMS) using Niagara software and Particle Measuring System (PMS) using FacilityPro software; generated BMS and PMS reports on time and involved in preparation of BMS and NVPC monthly and yearly trend documents. Responsible for initiating breakdown notifications in SAP.* Handling and archival of documents and logbooks pertaining to manufacturing area in an efficient manner. Prepared tracker using Microsoft Excel for issuance, archival and vendor management of logbooks.* Involved in material management of the manufacturing area.*Escorted visitors to the DP manufacturing area during facility visit and briefing them regarding the overall manufacturing process.* Followed cGMP practices and online documentation.
Other employees you can reach at pfizer.com. View company contacts for 112906 employees →
Jasper Heirewegh
Colleague at PfizerGhent Metropolitan Area, Belgium
View →
JA
Jessica Andy
Colleague at PfizerIstanbul, Türkiye, Turkey
View →
ME
Mona Esam
Colleague at PfizerEl Minya, Al Minya, Egypt
View →
FJ
Fan Jiang
Colleague at PfizerHastings-On-Hudson, New York, United States
View →
IT
Irene Tyrrell
Colleague at PfizerCounty Westmeath, Ireland
View →
EN
Elie Needle
Colleague at PfizerNew York City Metropolitan Area, United States
View →
EB
Elena Bell
Colleague at PfizerWashington, District Of Columbia, United States
View →
MG
Monica Garcia
Colleague at PfizerGreater Madrid Metropolitan Area, Spain
View →
SR
Shaymaa Radwan
Colleague at PfizerGiza, Al Jizah, Egypt
View →
AR
Amir Rotem
Colleague at PfizerIsrael
View →
Selected to be a part of the program from October 2018 - February 2019. Gained in-depth knowledge about the pharmaceutical industry.
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.
Quick answers generated from the profile data available on this page.
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 while working with Pfizer.
Harshitha Ramesh has worked for Pfizer and Biocon Biologics.
Harshitha Ramesh's colleagues at Pfizer include Jasper Heirewegh, Jessica Andy, Mona Esam, Fan Jiang, and Irene Tyrrell.
You can use AeroLeads to view verified contact signals for Harshitha Ramesh at Pfizer, including work email, phone, and LinkedIn data when available.
Harshitha Ramesh holds Biocon-Kgi Certificate Program In Biosciences, Biotechnology from Biocon Academy.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contactsCheck these profiles if this is not the Harshitha Ramesh you were looking for.
