Overview
Work History
Timeline
Summary
Skills
Education
Accomplishments
Software
Certification
Additional Information
Hi, I’m

A S MONISHA

Senior Associate Scientist
Chittoor
A S MONISHA

Overview

8
years of professional experience
6
years of post-secondary education
3
Certificates

Work History

Pfizer Healthcare India Pvt Ltd.
Chennai

Senior Associate Scientist
01.2021 - Current

Job overview

  • Conducted experiments in laboratory environment for product development purposes.
  • Documented changes during experiments, noting unexpected issues arising during research activities.
  • Execute business analysis process to facilitate function/design relationships within LIMS system including documentation.
  • Played key role for implementation of modules like Lot Management,Instrument Management,Stability Management in Labware LIMS.
  • Build and support Labware LIMS specific process like batch/Lot creation,quality disposition and sample chain of custody.
  • Experience in integrating Laboratory instruments with Labware LIMS.
  • Handling of queries related to LIMS by coordinating with global team.
  • Documented changes during experiments, noting unexpected issues arising during research activities

Dr.Reddy's Laboratories
Hyderabad

Analytical Scientist
08.2019 - 01.2021

Job overview

  • Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
  • Evaluated and implemented new technologies and laboratory techniques to improve quality and robustness of sample analysis.
  • Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
  • Monitoring deviations and CAPA initiation,action process,root cause analysis.
  • Initiation and Review of change control(gQTS) to create/update obsolete LIMS meta data.
  • Configure master data objects with respect to approved specification,standard test procedure &batch records.
  • Support IT team during internal and regulatory GMP Audits.

Pfizer Healthcare India Pvt Ltd.
Chennai

Research Executive
05.2016 - 05.2019

Job overview

  • Analytical method remediation, compendia compliance, Technology transfer, Co-development support, Ensuring minimal challenges in lifecycle management of methods.
  • Participate in Lab activities necessary to maintain compliance in lab.
  • Performed calibration of different analytical instruments as per master calibration schedule.
  • To ensure timely completion of assigned Training Modules and Skill Evaluation.
  • Performed ‘End to end’ master data gathering, coordination, management, data quality checks and entry to support hassle free temperature excursion studies.
  • Identify and enable Continuous Improvement projects & Site initiatives.
  • Established connections with liaisons to industrial and commercial stakeholders, allowing industry trends to inform research and vice versa

Central Drug Testing Laboratories
Chennai

Bench Chemist
11.2015 - 03.2016

Job overview

  • Performed analytical quality control of majority of imported drug available in Indian market.(Cosmetics includes facial creams, powders, lipsticks, soaps shampoos, rouges etc.,)
  • Performed analytical quality control of drug and cosmetics manufactured within country on behalf of Central and State Drug Controller Administrations.

Axon Drugs Pvt Ltd.
Chennai

Trainee Chemist
01.2015 - 09.2015

Job overview

  • Performed stability studies of pharmaceuticals (Formulations & API) as per ICH guidelines.
  • Performed analysis of raw materials, intermediates and finished products (Analgesics, antibiotics, vitamins& anti-hypertensive).
  • Performed routine calibration of sophisticated analytical instruments like HPLC, UV, FTIR etc.
  • Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties

Timeline

Senior Associate Scientist
Pfizer Healthcare India Pvt Ltd.
01.2021 - Current
Analytical Scientist
Dr.Reddy's Laboratories
08.2019 - 01.2021
Research Executive
Pfizer Healthcare India Pvt Ltd.
05.2016 - 05.2019
Bench Chemist
Central Drug Testing Laboratories
11.2015 - 03.2016
Trainee Chemist
Axon Drugs Pvt Ltd.
01.2015 - 09.2015
Sri Padmavathi School of Pharmacy
M.Pharmacy from Pharmaceutical Analysis
06.2013 - 04.2015
Vaasavi Institute of Pharmaceutical Sciences
B.Pharmacy
06.2009 - 04.2013

Summary

Determined and well-rounded individual with more than 8 years working as Senior Associate Scientist within bio-pharmaceutical industry. Skilled in conceptualization, design and implementation of LIMS projects. Develops creative business solutions, leveraging diverse methodologies and delivering engineering solutions for leading organizations.

Skills

    Project Management

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Education

Sri Padmavathi School of Pharmacy
Tirupati, AP

M.Pharmacy from Pharmaceutical Analysis
06.2013 - 04.2015

University Overview

CGP_82%

Vaasavi Institute of Pharmaceutical Sciences
Siddhavatam,Kadapa

B.Pharmacy
06.2009 - 04.2013

University Overview

CGP_81%

  • Qualified in GPAT-2013 and secured 401 all India rank
  • Qualified in PGECET-2013 and secured 206 state rank.

Accomplishments

Accomplishments
  • Certificate of Appreciation for the best performance for the year 2016 from Pfizer India for the establishment of PAT Technology to support formulation.
  • Q1 Mission award 2017: Reconstitution study to demonstrate the product compatibility of Penicillin’s and carbapenem’s to address the USFDA query.
  • Q3 Mission award 2018: Alternative method development and Co validation of carbapenem, penicillin’s & aminoglycosides for cross contamination study by UPLC.
  • Team of the Month _ January 2018: Best Team of the month award (January 2018) for the Melt back study characterization of antibiotics.

Software

Labware LIMS

Empower

FTNIR-OPUS 75

BIOVIA ELN

Certification

LC trouble shooting by Waters

Additional Information

Additional Information

I hereby declare that the information furnished above is true and correct to the best of my knowledge.


Monisha A S

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A S MONISHASenior Associate Scientist