HEMAKALYANI KARRI
F R&D
VISAKHAPATANAM,ANDHRA PRADESH
Summary
Seeking a challenging role where I can leverage my skills, knowledge, and passion for pharmaceutical innovation
Experienced Master of Pharmacy with a solid background in pharmaceutical formulations and analytical research and development, complemented by around 6 years of industry experience. Proven expertise in various facets of the field, including formulation development, analytical testing, and adherence to regulatory standards. Demonstrated exposure to US FDA inspections, ensuring compliance and maintaining high-quality standards. Known for a strong work ethic, unwavering commitment to excellence, and a dedicated approach to achieving organizational goals. Seeking a challenging role where I can leverage my skills, knowledge, and passion for pharmaceutical innovation to drive advancements in the industry. Polished Quality Analyst with over 6 years of experience providing knowledge and expertise in quality assurance field. Works independently and prioritizes multiple tasks concurrently. Competent in SQL, SSIS and QA methodologies.
Overview
6
6
years of professional experience
Work History
Quality Control Analyst
Teva pharmaceuticals
Chennai
08.2023 - Current
- review of Stability products.
- Preparing the analytical test procedures, Stability Protocols, Method validation protocols and reports, method transfer protocols and reports, SOPs and stability protocols, and reports
- Assist data reviewer in the checking of R&D analytical data generated and maintain the instrument calibrations.
- Ensure availability of the required standards/columns and reagents for R&D projects - Prepare responses to customer and Authority technical queries for analytical issues in coordination with the relevant formulator
Research Associate
Laurus Labs
Hyderabad
07.2021 - 07.2023
- Conduct stability studies on pharmaceutical formulations to assess their quality and performance over time
- Perform analytical testing and analysis of stability samples using various techniques such as HPLC, UV-Vis, dissolution testing, and physical characterization
- Monitor and document stability study parameters including temperature, humidity, and storage conditions to ensure compliance with regulatory guidelines
- Evaluate stability data and generate comprehensive reports summarizing the results and providing recommendations for formulation improvement or adjustment
- Collaborate with cross-functional teams including formulation scientists, quality control, and regulatory affairs to support formulation development and provide stability-related insights.
Senior Research Associate
Suven Life sciences Limited
Hyderabad
12.2017 - 04.2021
- US FDA audit faced in in November 2019
- Developed Assay and Dissolution methods using HPLC
- Supported regular and stability analysis for formulation development
- Conducted pre-formulations and performed analytical testing using HPLC, Dissolution, Karl Fischer, and UV-Vis for both in-house and external products
- Demonstrated proficiency in various analytical techniques, including HPLC, UV spectrophotometer, dissolution apparatus, disintegration apparatus, Karl Fischer titrator, and wet chemical analysis
- Conducted test analysis for Assay, blend uniformity, content uniformity, RS, moisture content, and cleaning validation
- Created custom fields in HPLC software (Empower3)
- Analysed in-process and finished products of oral solid dosage forms (tablets, granules, capsules, pellets, and films) in accordance with standard testing procedures and specifications
- Performed IVRT studies using Franz diffusion cell apparatus
- Familiarity with regulatory guidelines concerning method development and documentation
- Interpreted data based on analytical results obtained from experiments
- Calibrated and troubleshoot analytical instruments such as HPLC, dissolution apparatus, and disintegration apparatus
- Conducted instruments qualification and performance qualification as per regulatory requirements
- Regularly calibrated pH meters and balances
- Possessed a solid understanding of documentation in compliance with GLP requirements
- Prepared and reviewed finished product analytical specifications and Standard Testing Procedures (STPs) as per requirements
- Generated analytical documents, including development reports, validation protocols/reports, test methods, and experimental results.
Education
Master of Pharmacy - Pharmaceutical Analysis & Quality Assurance
Andhra University College of Pharmaceutical Sciences
01.2017
Master of Pharmacy - Pharmaceutical Analysis & Quality Assurance
Andhra University College of Pharmaceutical Sciences
01.2017
Bachelor of Pharmacy -
Vignan Institute of Pharmaceutical Technology
01.2015
Bachelor of Pharmacy -
Vignan Institute of Pharmaceutical Technology
01.2015
Intermediate - Bi.P.C
Board of Intermediate Education
01.2011
Intermediate - Bi.P.C
Board of Intermediate Education
01.2011
Matriculation - S.S.C
Board of Secondary School Education
01.2009
Matriculation - S.S.C
Board of Secondary School Education
01.2009
Skills
- Proficient in MS Office tools
- Able to search scientific literature on-line
- Assay development
- HPLC analysis/Expertise
- Analytical techniques
- Physical characterization
- UV-Vis analysis
- Karl Fischer titration
- Wet chemical analysis
- Test analysis skills
- Oral solid dosage
- Regulatory affairs
- Instrument calibration
- Troubleshooting skills
- SOP Development
- Performance Assessment
- Quality Improvement
- Protocol Review
- Report Creation
Software Instruments Handled
- HPLC (make: Waters, Shimadzu LC-2010C, Agilent 1200,1260 infinity, Shimadzu LC-2030C Prominence I)
- UV-visible spectrophotometer
- Flow through cell dissolution tester
- Dissolution (Electro Lab), (Lab India DS8000, Auto & manual, DISTEK-2500)
- Workstation: Empower-3, LAB solutions (HPLC), open lab software, ChemStation, EZchrome elite. Potentiometry Auto-titrator
Personal Information
- Father's Name: Srinivasa Gandhi
- Date of Birth: 08/05/1994
- Nationality: Indian
- Marital Status: Single
Languages
English, Hindi & Telugu
Timeline
Quality Control Analyst
Teva pharmaceuticals
08.2023 - Current
Research Associate
Laurus Labs
07.2021 - 07.2023
Senior Research Associate
Suven Life sciences Limited
12.2017 - 04.2021
Master of Pharmacy - Pharmaceutical Analysis & Quality Assurance
Andhra University College of Pharmaceutical Sciences
Master of Pharmacy - Pharmaceutical Analysis & Quality Assurance
Andhra University College of Pharmaceutical Sciences
Bachelor of Pharmacy -
Vignan Institute of Pharmaceutical Technology
Bachelor of Pharmacy -
Vignan Institute of Pharmaceutical Technology
Intermediate - Bi.P.C
Board of Intermediate Education
Intermediate - Bi.P.C
Board of Intermediate Education
Matriculation - S.S.C
Board of Secondary School Education
Matriculation - S.S.C
Board of Secondary School Education
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