Kalyani Nallala
Secunderabad
Summary
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
12.2022 - 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
01.2015 - 12.2022
- 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
12.2013 - 12.2014
- Performed testing of intermediates by using GC, HPLC, KF.
- Maintenance of GMP and GLP procedures.
Education
B. Pharmacy -
VAAGDEVI INSTITUTE OF PHARMACETICAL SCIENCES, KU
Warangal05-2011
M.Pharmacy -
MALLAREDDY COLLEGE OF PHARMACY, OU
Hyderabad12-2013
Intermediate CBSE -
JAWAHAR NAVODAYAVIDYALAYA
CHOPPADANDI05-2006
10th CBSE -
JAWAHAR NAVODAYA VIDYALAYA
CHOPPADANDI05-2004
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
12.2022 - Current
Assistant Manager in Quality Control
GLAND PHARMA Pvt.Ltd
01.2015 - 12.2022
Chemist in Quality Control
SEUTIC PHARMA Pvt Ltd
12.2013 - 12.2014
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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