Summary
Overview
Work History
Education
Skills
Audits faced
Projects handled & Papers published
Skills
Timeline
Generic

Kalyani Nallala

Secunderabad

Summary

Expert in quality assurance and quality control within bio-pharma and pharma sectors, leveraging technical intelligence to enhance quality systems. Proven track record of implementing effective quality management strategies that meet global standards. Committed to driving continuous improvement and ensuring compliance with regulatory requirements.

Overview

12
12
years of professional experience

Work History

Deputy Manager in Quality Assurance

CURATEQ BIOLOGICS Pvt.Ltd
Hyderabad
12.2022 - Current
  • Guided team in reviewing quality control documents, including analytical data and COA for drug products and substances in LIMS.
  • Reviewed method validation protocols and reports to ensure accuracy.
  • Evaluated OOS incidents, deviations, and change controls within Agile QMS systems.
  • Verified CAPA effectiveness to maintain compliance with industry standards.
  • Assisted in internal and external audits to support quality assurance initiatives.
  • Reviewed stability protocols and reports to assess product integrity over time.
  • Monitored compliance across processes while training new team members on QC activities.
  • Collaborated with production teams to identify and resolve quality issues, enhancing product quality.

Assistant Manager in Quality Control

GLAND PHARMA Pvt.Ltd
Hyderabad
01.2015 - 12.2022
  • Managed and mentored team to drive continuous improvement initiatives.
  • Developed and implemented CAPAs, resulting in reduced error rates.
  • Prepared and reviewed investigations for OOS, OOT, deviations, and LIRs.
  • Reviewed SOPs, STPs, method validation protocols, and reports for compliance.
  • Trained new personnel in various testing methods utilizing HPLC techniques.
  • Maintained GMP and GLP systems to ensure regulatory compliance.
  • Utilized Empower, Lab Solutions, and LIMS software for efficient data management.

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

M.Pharmacy -

MALLAREDDY COLLEGE OF PHARMACY, OU
Hyderabad
12-2013

B. Pharmacy -

VAAGDEVI INSTITUTE OF PHARMACETICAL SCIENCES, KU
Warangal
05-2011

Intermediate CBSE -

JAWAHAR NAVODAYAVIDYALAYA
CHOPPADANDI
05-2006

10th CBSE -

JAWAHAR NAVODAYA VIDYALAYA
CHOPPADANDI
05-2004

Skills

  • GXP document review
  • Technical investigation analysis
  • Compliance monitoring
  • Method transfer management
  • Electronic document handling
  • Team leadership
  • Quality control management

Audits faced

  • USFDA
  • MHRA
  • ANVISA
  • EMA
  • FDA
  • Various customers audits

Projects handled & Papers published

  • 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.
  • Quality Assurance.
  • Quality Management.
  • Method validation and method transfer
  • Technological expertise in Biosimilar and injectable products.
  • Batch records and COA, SOP, Protocols,trend.
  • LIMS, Electronic Document Management, Electronic Training Management, Aglie(QMS).
  • H.P.L.C Waters Shimadzu, agilent.
  • UV-SHIMADZU.
  • CHROMATOGRAPHY – TLC.
  • GC-CHEMITO.
  • KF-Titrator-Datla Instruments.

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

M.Pharmacy -

MALLAREDDY COLLEGE OF PHARMACY, OU

B. Pharmacy -

VAAGDEVI INSTITUTE OF PHARMACETICAL SCIENCES, KU

Intermediate CBSE -

JAWAHAR NAVODAYAVIDYALAYA

10th CBSE -

JAWAHAR NAVODAYA VIDYALAYA

Similar Profiles

CREATE PROFILE
Kalyani Nallala