S. KISHAN REDDY
Summary
Quality control professional with over 12. years of experience in formulation for both injectables and oral solid dosage forms, complemented by extensive laboratory exposure. Committed to leveraging a unique blend of skills, knowledge, and qualifications to contribute effectively to organizational growth while pursuing a challenging career in quality assurance. Dedicated to fostering a collaborative and innovative work environment that embraces cutting-edge practices within the discipline. Proven ability to work as a team player, consistently striving to achieve organizational goals and deliver exceptional results.
Overview
12
12
years of professional experience
1
1
Language
Work History
Sr. Executive - Quality Control
AET Laboratories Pvt. Ltd.
07.2022 - Current
- Preparation and Review of protocols and Reports for the Analytical method verifications for Drug Substances and Excipients of USP-NF and Ph.Eur monograph molecules as per ICH guidelines.
- Preparation and Review of Standard operating procedure as per OMCL guidelines and USP General chapters.
- Preparation and Review of Specification and standard test procedure as per USP–NF and Ph. Eur monographs.
- Handling, qualification and maintenance of Working standards.
- Handling of Change control and Deviation, Out of specification, Out of Calibration, Out of expectation results and Laboratory incidents in quality control laboratory.
- Preparation of master calibration schedules and performing the calibration of Instruments like HPLC and GC.
- Procurement of Reference standards from Compendial and Non-Compendial sources.
- Review of Audit trail reports in Empower and standalone software as per schedules.
- Successful coordination for the various audits like USFDA, BJV and WHO.
Sr. Executive- Quality control
Aurobindo Health care Ltd. Unit I
01.2021 - 07.2022
- Performing analysis various techniques like assay, Related substance by HPLC and Residual solvents by GC for Raw material, Excipients.
- Performing the periodic calibration of analytical instruments like High performance liquid chromatography (HPLC) and Gas Chromatography (GC).
- Initiating and handling of Out of Specification (OOS) and PNC (Process Non-Conformances).
- Involving in the Investigative analysis out of specification and PNC (Process Non-Conformances).
- Review of HPLC sample set and Dissolution testing online verification as per the specified checklist.
Team Leader - Quality Control
Evergreen Life Sciences Limited (Formerly Optimus Generics Limited)
06.2017 - 10.2020
- Planning of Raw material, packing material, IP&FP Samples.
- Review of Raw material, packing material IP&FP Samples.
- Review and approvals of Raw material, packing material IP&FP Samples in LIMS software.
- Review of Specifications, standard test methods (STP) and standard operating procedures (SOP).
- Investigating the Out of Specification (OOS) and Laboratory incidents.
- Initiating and handling of Change controls and Deviations related to Q.C.
- Conducting internal Trainings related to LAB COMPLIANCE.
- Successful coordination for the various audits like USFDA, MHRA and TGA.
Executive - Quality Control
Aurobindo Pharma Ltd. Unit IV
09.2013 - 06.2017
- Performing analysis of Raw material, in-process samples and finished dosages (injectables).
- Evaluation and Maintenance of the Working Standards, Reference Standards.
- Critical analysis like Diluent Compatability Studies for ANDA Submissions Planning and Reviewing of Studies.
- Periodic calibration of Analytical Instrument like HPLC, UV-Vis.Spectrophotometer KF Apparatus & FTIR.
- Work experience in Caliber LIMS Environment.
- Analyzing and investigating the Out Of Specification.
- Involves in regular in-house GLP training activities and compliance.
- Successful coordination for the various audits like USFDA, MHRA, ANVISA TGA and WHO.
Education
Masters of Pharmacy -
Talla Padhmavati Institute of pharmaceutical sciences
Warangal01.2014
Bachelor of Pharmacy - undefined
Max Institute of Pharmaceutical Science
Khammam01.2011
Skills
Operation and calibration of HPLC :Make: Waters, Shimadzu and Agilent with Software: Empower 328 and Chromeleon 72
Operation and Calibration of GC Make: Agilent-GC 7890A, Make: Perkin-elmer, Model-Clarus HS-240 Software: Empower328
Operation and Calibration of UV-Visible Spectrophotometer (Make: Shimadzu Model: UV-2600 Software UV-Probe)
Operation and Calibration of KF Apparatus (Software-Tiamo)
Operation of Malvern Mastersizer 3000
Work experience in Caliber LIMS Environment
Sound Knowledge on Analytical method verification and method Validation
DECLARATION
I consider myself with the above-mentioned aspects. I hereby declare that the above details furnished are true to the best of my knowledge and belief. (S. Kishan Reddy)
Timeline
Sr. Executive - Quality Control
AET Laboratories Pvt. Ltd.
07.2022 - Current
Sr. Executive- Quality control
Aurobindo Health care Ltd. Unit I
01.2021 - 07.2022
Team Leader - Quality Control
Evergreen Life Sciences Limited (Formerly Optimus Generics Limited)
06.2017 - 10.2020
Executive - Quality Control
Aurobindo Pharma Ltd. Unit IV
09.2013 - 06.2017
Bachelor of Pharmacy - undefined
Max Institute of Pharmaceutical Science
Masters of Pharmacy -
Talla Padhmavati Institute of pharmaceutical sciences