S. Ravindraprasad
Thumukunta
Summary
Result-oriented Professional with 13 years of experience; targeting senior level assignments in Quality Control with an esteemed organization
Experienced in Quality Control of Pharma Products like injectables, tablets, API's. Exhibited excellence by managing incidents, deviations, change controls, OOS, OOT & out of calibration events; conducted root cause analysis and implemented appropriate corrective & preventive measures and analytical instrument troubleshooting while ensuring C-GLP and safety systems. Gained extensive knowledge on Pharmaceutical analysis including HPLC, GC, IC, FTIR, UV, KF,XRD,PSD,ICPMS, Dissolution and Wet Chemistry techniques Coordination with team members to assign and completion of the work within the timelines. Skilled in coping up with difficult situations in an assured & firm manner; possess a go-getter attitude along with determination & positive approach
Overview
18
18
years of professional experience
Work History
Assistant Manager QC
Eugia Pharma specialities Ltd
08.2016 - Current
- Hands on experience in handling investigations of laboratory incidents.
- Experience in handling investigations of OOS (Out of specification) and OOT (Out of trends) in quality control.
- Root cause analysis and impact evaluations.
- Coordination with cross functional teams for release of product/material and timely closure of QMS documents.
- Conducting root cause analysis for OOS and incidents, implemented appropriate corrective & preventive measures.
- Involved in handling of CAPA's (Corrective and preventive actions).
- Involved in QMS trainings for the human errors and awareness trainings.
- Quarterly and Annual trending of laboratory incidents and OOS.
- Involved in audit and compliance activities.
- SOP revision and change controls handling.
- Reviewing of chromatographic data audit trails and other software audit trails.
- Reviewing of reports through laboratory information management system.
- Supervision of shift activities like shift report, shift planning for analysis to avoid delay of Analysis.
- Handling of deviations and excursions handling.
- Review of documents and planning of Raw materials work allotments.
- Processing of chromatographic data.
- Review of Stability, Raw material finished and in-process analytical documents.
- Review experience in analytical method verification and method transfer.
- Review of Specifications, STP and LIMS test plans.
- Preparation and qualification of working standards.
- Subsidary of Aurobindo pharmaltd
- Supervised inspection of laboratory on daily basis which improved the compliance and inspection readiness.
- Directed QMS to ensure change controls, deviations, CAPA and reviewed & approved documentation changes.
- Steered the implementation of quality initiatives such as procedures improvement.
- Responsible for planning internal audits within the department.
- Implementation and monitoring of GLP in the Laboratory.
- Participated in USFDA, MHRA and other regulatory audits.
OFFICER - QC
Lupin laboratories Ltd
06.2015 - 07.2016
- Involved in Raw materials Department HPLC Analysis, Particle size Analysis and XRD Analysis.
- Approved by USFDA, MHRA, GOA
ROB member - QC
Dr Reddys Laboratories limited
01.2012 - 06.2015
- Involved in HPLC and GC analysis of raw materials, in-process and finished products.
- Calibration of analytical equipments like High performance Liquid chromatography and other instruments.
- Formulations (FDA, MHRA & TGA Approved)
Analyst
Kalvik Laboratories Ltd
06.2008 - 01.2012
- Involved in sampling, wet analysis and HPLC analysis.
- Formulations (WHO and USFDA Approved)
Education
B.Sc. - Biochemistry, zoology and Chemistry
Kakatiya University
Telangana01.2015
M.Sc. - Organic Chemistry
Osmania University
Telangana01.2012
Skills
- Quality Control
- Quality Assurance
- Analysis planning
- Monitoring
- Review
- Release of product/materials
- QMS activities
- OOS
- Deviations
- Change controls
- CAPA
- Analytical method verification
- Analytical method transfer
- Review of Analytical data
- Internal Inspections
- HPLC
- GC
- IC
- FTIR
- UV
- XRD
- PSD
- ICPMS
- KF
- Project Coordination
- Project Execution
- Internal inspection
- Compliance
Languages
- English
- Hindi
- Tamil
- Telugu
- English
- Hindi
- Tamil
Disclaimer
I hereby declare that the above-furnished details are true and correct to the best of my knowledge.
Instruments Used
- HPLC (Make: Waters 2695-Empower-3, Agilent-1260)
- GC (Make: Agilent 7890A)
- UV/Vis Spectrometer (Make: Perkin Elmer)
- Dissolution Apparatus (Make: Electrolab)
- FTIR-Spectrophotometer (Make: Perkin Elmer)
- KF titrator (Make: Metrohm)
- Ion-Chromatography (Metrohm)
- Particle size analyzer (Malvern Mastersizer 3000)
- X-Ray Diffractometer (Bruker)
- ICPMS (Thermo Scientific)
- Density meter
- Osmometer
Personal Information
- Father's Name: Mallaiah
- Date of Birth: 11/05/83
- Marital Status: Married
Timeline
Assistant Manager QC
Eugia Pharma specialities Ltd
08.2016 - Current
OFFICER - QC
Lupin laboratories Ltd
06.2015 - 07.2016
ROB member - QC
Dr Reddys Laboratories limited
01.2012 - 06.2015
Analyst
Kalvik Laboratories Ltd
06.2008 - 01.2012
B.Sc. - Biochemistry, zoology and Chemistry
Kakatiya University
M.Sc. - Organic Chemistry
Osmania University