Shalaka Kharat
R&D Officer
Pune
Summary
To be associated with an organization that would provide a challenging, innovative, inspiring work atmosphere that will utilize individual excellence & knowledge to contribute in company’s growth along with own growth.
Overview
2
2
years of professional experience
8
8
years of post-secondary education
Work History
R & D Officer
Agio Pharmaceuiticals LTD.
07.2022 - Current
- Department Analytical Research and development Laboratory (Analysis of manufactured medicine)
- To work in ARDL department as a GLP officer, Maintain GDP
- Perform calibration of all instruments (HPLC with Software- Lab Solution & Chromeleon 6.8)(UV/PDA) And pH meter,Analytical Balance,UV spectrophotometer,Dissolution test apparatus)
- Perform activities, reporting to Head and maintaining documents
- Execute analytical testing of received sample(R&D Trial batches) according to specification of USP,BP and IP monoghraph
- Execute analysis of Product that Query from Quality Control Department,Handling of Market Compliant
- Preparing or revision SOPs through the procees of Change control By Quality Assurance Department
- Good Laboratory Practices(GLP),Good Documentation Practices(GDP),Good Manufacturing Practices(GMP) with respect to Regulatory Guidelines
- Data integrity, Change control, Deviations, Root cause, CAPA, OOS, OOT, Incidence.
- Knowledge of Clinical Research, Clinical trial, Drug Discovery, Good clinical practices, Clinical trial phases, Different stakeholders_CR, Nuremberg code and their history, Declaration of Helsinki, ICH guidelin (GCP-13 Principals), TMF, eTMF, Essential documents, INDA, NDA, ANDA, Amendment, Adverse drug reaction, Adverse drug event, Audit, CRF, Single and Double blinded studies, Pharmacovigilance, Rechallenge & Dechallenge, Triage,Medra dictionary,Argus, Causality, Duplicate Research, Source of document in pharmacovigilance.
Education
Msc.Analytical chemistry -
Savitribai Phule Pune Univercity
Pune 08.2019 - 06.2021
Bsc (Chemistry) -
Savitribai Phule Pune Univercity
Pune 05.2016 - 06.2019
H.S.C -
Maharashtra Board
Pune 06.2014 - 06.2015
S.S.C -
Maharashtra Board
Pune 06.2012 - 06.2013
Clinic Research Cirtificate Course - Clinical Research
Udemy
Pune 08.2023 - 09.2024
Skills
Good clinical practice (GCP)
Good manufacturing practice (GMP)
Good Documentation practice (GDP)
Ms Excel, MS Word
Coursedetails
- Pharmaceutical Industry ready certification course, 2021
- Clinical Research Certificate Course, 2023
Personal Information
- Date of Birth: 07/07/97
- Gender: Female
- Marital Status: Unmarried
Disclaimer
I Shalaka Kharat declare that the above information is factually correct to the best of my knowledge & belief. In case if any of the above information at any time found incorrect, then I shall be liable for immediate termination & this would be deemed as part of the contract employment.
Timeline
Clinic Research Cirtificate Course - Clinical Research
Udemy
08.2023 - 09.2024
R & D Officer
Agio Pharmaceuiticals LTD.
07.2022 - Current
Msc.Analytical chemistry -
Savitribai Phule Pune Univercity
08.2019 - 06.2021
Bsc (Chemistry) -
Savitribai Phule Pune Univercity
05.2016 - 06.2019
H.S.C -
Maharashtra Board
06.2014 - 06.2015
S.S.C -
Maharashtra Board
06.2012 - 06.2013
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