SRINIVASA NAVEEN KUMAR VEMPATI
Jaggaiahpet (V)
Summary
To associate myself with an organization that provides me an opportunity to show my skills & ability, will prosper the organization, improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization.
Overview
12
12
years of professional experience
Work History
Quality Control –Asst. Manager
Integrin lifesciences Pvt. Ltd
Jaggaihapeta
11.2022 - Current
- Planning for QC day-to-day shift activities.
- Daily and monthly audit trail review in Empower software.
- Monthly backup and daily backup activities in Empower software.
- Planning and review of analytical method validations and method verifications, as per pharmacopoeia.
- Analysis review and approvals of finished product, raw material, and intermediates.
- Review and approvals of Standard test procedures (STP’s) and standard operating procedure (SOP’s)
- Responsible for laboratory investigation of Out of Specification, out of trend, and laboratory incidents, and related CAPA implementations and effectiveness verification.
- Review of IQ, OQ, and PQ.
- Coordinate the regulatory queries and Pharmacopoeial monograph updates.
- Pharmacopoeia reference standards and working standards maintenance.
Quality Control –Asst. Manager
Clininvent research Pvt. Ltd
09.2020 - 11.2022
- Planning for method transfer and method validation activities
- Preparation and Review of Cleaning Validations, Method Validations and Method Transfers Protocols and Reports
- Data and Audit trail review in Empower3 Software
- Audit trail review in UV, IR, Auto titrator and KF Titrator instruments
- Coordinating with Internal & External Auditing
- Coordinating with External agencies for Calibrations and Preventive maintenance
- Planning for QC day to day shift activities
- Review and Approvals of Daily calibrations, Monthly, Quarterly and Annual calibrations
- Preparation and review of Standard test procedures (SOP’s) and Standard Test Procedures (STP’s)
- Review and Approvals of Raw material, in-Process, intermediate and Finished Samples Data
- Responsible for laboratory investigation of Out of Specification, out of trend and laboratory incidents and related CAPA implementations and effectiveness verification Handling of the Quality control department in absence of QC Head.
Analytical Research and Development -Sr. Executive
Cronus research labs Pvt. Ltd
07.2017 - 09.2020
- Execution of HPLC and GC method Validations and Development for test methods like related Substances, assay and Residual solvents for active pharmaceutical ingredients and for intermediates according to ICH guidelines
- Preparation of Development Protocol& reports and validation Protocol& reports for API products, Stress degradation reports, Absence studies for any impurities, intermediates and as per regulatory requirements
- Forced degradation studies and impurity profiling by using PDA
- Preparation and Review of Cleaning Validations, Method Validations and Method Transfers Protocols and Reports
- Technology Transfer from R&D to Q.C for various APIs
- Preparation and Maintain the Finished product, Intermediate and Impurity Reference Standards
- Troubleshooting the hardware components of analytical instruments
- Analysis of finished Drugs according to pharmacopeias standards and preparation of COA’s
- Maintain the GLP Documentation
- Preparation and control of Standard Operating Procedure (SOP), Standard Test Procedure (STP) and Protocols.
Quality Control –Executive
Symed Labs Ltd
Bonthapally, Hyderabad
05.2015 - 06.2017
- Handling of LIMS Software
- (Version 3.2.1E and 3.5.0)
- Preparation and Review of Finished, Intermediate, In-Processes, Stability Analysis and All type of Calibration Documentation in LIMS Software
- Preparation and Review of Test planes and Worksheets in LIMS
- Preparation and Review of Stability Studies protocols and data
- Finished Product, Stability Studies, Raw Materials and Intermediate Analysis
- Handling & Review of Change controls, Deviations and Incidents
- Calibrations of All Instruments (Like HPLC, GC, UV, IR, Auto titrator and Polarimeter)
- Verification of working standards, Reference standards, Primary standards storage condition/status/validity and review of reference standard catalog
- Maintain and review of Electronic data backup and Data Integrity
- Handling of the Quality control department in absence of QC Head.
QC-Sr. Chemist
Azakem Labs Pvt. Ltd
Bidar
04.2012 - 04.2015
- Finished Product, Raw Materials and Intermediate Analysis
- Calibrations of Instruments (HPLC, GC, UV, IR and Polarimeter)
- Analysis of Moisture content, Sulphated Ash content, and Loss on Drying
- Preparation and Standardization of normal solutions.
Education
Master of Science - Organic Chemistry
Osmania University
01.2015
Bachelor of Science - M.C.C’s
Kakathiya University
01.2012
Board of Intermediate - M.P.C
01.2009
Board of SSC -
01.2009
Skills
- Good Knowledge on Empower Software
- Caliber LIMS 321 E Software
- online and daily Audit trails in CD's and Non-CD's Systems
- Analytical method validations
- Analytical method transfers
Personal Information
- Date of Birth: 04/07/92
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
Telugu, English, Hindi
Disclaimer
I hereby declare that the above mentioned details are true to the best of my knowledge.
Timeline
Quality Control –Asst. Manager
Integrin lifesciences Pvt. Ltd
11.2022 - Current
Quality Control –Asst. Manager
Clininvent research Pvt. Ltd
09.2020 - 11.2022
Analytical Research and Development -Sr. Executive
Cronus research labs Pvt. Ltd
07.2017 - 09.2020
Quality Control –Executive
Symed Labs Ltd
05.2015 - 06.2017
QC-Sr. Chemist
Azakem Labs Pvt. Ltd
04.2012 - 04.2015
Master of Science - Organic Chemistry
Osmania University
Bachelor of Science - M.C.C’s
Kakathiya University
Board of Intermediate - M.P.C
Board of SSC -
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