To work in a globally competitive environment by utilizing technical intelligence of Quality systems technically expertise in quality assurance and quality control in bio-pharma and pharma industries.
Overview
11
11
years of professional experience
Work History
Deputy Manager in Quality Assurance
CURATEQ BIOLOGICS Pvt.Ltd
Hyderabad
2022.12 - Current
Review of method validation Protocols and reports and Life cycle management of reports for its performance.
Review of Batch records and COA of drug product and drug Substances.
Review of OOS, Deviations, LIRS, change controls in agile systems.
Internal and external audits.
Review of stability Protocols and reports.
Assistant Manager in Quality Control
GLAND PHARMA Pvt.Ltd
Hyderabad
2015.01 - 2022.12
Prepared investigations for OOS, OOT, deviations and LIRs.
preparation and review SOPs, STPs, method validation protocols and reports.
Training and assisting of new individuals in testing of various methods by using HPLC techniques.
Maintenance of GMP and GLP systems.
Handled software like Empower, Lab solutions.
Chemist in Quality Control
SEUTIC PHARMA Pvt Ltd
Hyderabad
2013.12 - 2014.12
Performed testing of intermediates by using GC, HPLC, KF.
Maintenance of GMP and GLP procedures.
Education
B. Pharmacy -
VAAGDEVI INSTITUTE OF PHARMACETICAL SCIENCES, KU
Warangal
2011-05
M.Pharmacy -
MALLAREDDY COLLEGE OF PHARMACY, OU
Hyderabad
2013-12
Intermediate CBSE -
JAWAHAR NAVODAYAVIDYALAYA
CHOPPADANDI
2006-05
10th CBSE -
JAWAHAR NAVODAYA VIDYALAYA
CHOPPADANDI
2004-05
Skills
Review of GXP documents including SOPs, stability protocols and reports, qualification protocols and reports.
Review of technical investigations and reports in related to OOS, deviations, change control CAPAs in AGILE application.
Compliance monitoring
Management of method transfer and method validation protocols and reports.
Handling of Atachi electronic document management system, Atachi electronic training management system, Agile, LIMS (Caliber).
Audits faced
USFDA
MHRA
ANVISA
EMA
FDA
Various customers audits
Projects handled
Method development and method validation of four flouroquinolones by liquid chromatography
A Validated UV spectrophotometric method for the estimation of Ambrisentan in pure and tablet dosage forms in INVENTI RAPID:PHARMA ANALYSIS AND QUALITY ASSURANCE.
A Validated UV spectrophotometric method for the estimation of Anagralide in bulk and pharmaceutical dosage forms in INTERNATIONAL JOURNAL PHARMACY.
Skills
Continuous Learning.
GMP Procedures.
Ambiguity.
Quality Assurance.
Quality Management.
Method validation and method tarnsfer
Technological expertise.
Batch records and COA, SOP, Protocols,trend.
LIMS, Electronic Document Management, Electronic Training Management, Aglie.
H.P.L.C Waters Shimadzu, agilent.
UV-SHIMADZU.
CHROMATOGRAPHY – TLC.
GC-CHEMITO.
KF-Titrator-Datla Instruments.
Languages
English
Hindi
Telugu
Timeline
Deputy Manager in Quality Assurance
CURATEQ BIOLOGICS Pvt.Ltd
2022.12 - Current
Assistant Manager in Quality Control
GLAND PHARMA Pvt.Ltd
2015.01 - 2022.12
Chemist in Quality Control
SEUTIC PHARMA Pvt Ltd
2013.12 - 2014.12
B. Pharmacy -
VAAGDEVI INSTITUTE OF PHARMACETICAL SCIENCES, KU
M.Pharmacy -
MALLAREDDY COLLEGE OF PHARMACY, OU
Intermediate CBSE -
JAWAHAR NAVODAYAVIDYALAYA
10th CBSE -
JAWAHAR NAVODAYA VIDYALAYA
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