Labware LIMS
Hi, I’m
A S MONISHA
Senior Associate Scientist
Chittoor
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 LaboratoriesHyderabad
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 LaboratoriesChennai
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
Teamwork and Collaboration
Excellent Communication
Analytical and Critical Thinking
Education
Sri Padmavathi School of PharmacyTirupati, AP
M.Pharmacy from Pharmaceutical Analysis
06.2013 - 04.2015
University Overview
CGP_82%
Vaasavi Institute of Pharmaceutical SciencesSiddhavatam,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
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