Jenifer A
Chennai
Summary
Seeking growth oriented opportunities in Quality Control/ Quality Assurance
Motivated and proactive individual with considerable experience of implementing effective quality control processes in a corporate environment & possessing a good understanding of the essentials of safety and quality.
Overview
11
11
years of professional experience
Work History
SENIOR QA ASSOCIATE
NOVITIUM LABS PVT LTD
CHENNAI
04.2024 - Current
- Engaged in responsible with reviewing of analytical documents.
- Handling of OOT OOS Deviation and incident during analysis, batch release ETC.,
- Performing facility is approved by regulatory authorities like USFDA & cGMP.
Quality Control Analyst II
Teva Pharmaceutical Industries Ltd.
Chennai
11.2013 - 04.2024
- Company Overview: Teva Pharmaceutical Industries Ltd
- (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Petah Tikva, Israel
- It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals
- The company is certified with US-FDA & MHRA
- Performed role of QC Analyst in the Production Procedure Control unit facilitating analysis of finished products and stability samples for clients from Serbia, Iceland, Elizabeth, Norway, Canada, Germany and other European Countries
- Performing stability analysis by HPLC for Oral Solid Dosages and capsules
- Maintaining the consumption records of working Standards, and reference standards
- HPLC Column management
- Analysis of Dissolution profiles by UV Visible Spectrophotometer
- Performing Assay and Related substances by HPLC
- Physical testing of Oral solid dosages by using Friability, Hardness tester, Disintegration and moisture content by Karl Fischer instrument
- Teva Pharmaceutical Industries Ltd
- (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Petah Tikva, Israel
- It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals
- The company is certified with US-FDA & MHRA
- Operated as part of the Quality Control unit as a Quality Control Analyst II
- Proficient in SOP, GLP/GCP, CGMP and other industry standards
- Strong analytical skills in validation of process development methods in case of Product specification failure (OOS, OOT)
- Have experience in facing USFDA and MHRA (UK) audits
- Compilation of stability data with previously completed projects
- Preparation of Stability study specifications, Stability Summary Reports for samples, Method Transfer Protocol and SOP's for instruments
- Reviewing of Analytical data
- Responsible for GLP related documents
- Preparation of CAPA reports, Handling of OOS and Deviations and preparing the investigation reports of the same
Education
Master of Science (MSc) - Chemistry
MadrasChristian College
01.2013
Bachelor of Science (BSc) - Chemistry
Madras Christian College
01.2011
Skills
- HPLC with Empower-3 software
- UPLC with Empower-3 software
- UV Visible Spectrophotometer
- Dintegration Apparatus
- Dissolution Apparatus
- Friability
- Hardness Tester
- Karl Fischer
- GMP
- Validation
- SOP
- FDA
- Quality System
- GLP
- Stability Analysis
Disclaimer
I hereby declare that the information furnished above is true to best of my knowledge and belief.
Skillsandexpertise
HPLC with Empower-3 software-Waters and Agilent series., UPLC with Empower-3 software-Waters Series., UV Visible Spectrophotometer (SHIMADZU, AGILENT, UV)., Dissolution Apparatus (Vankel, Hanson, Distek and Electrolab)., Friability (ELECTRO LAB)., Hardness Tester (SOTAX)., Karl Fischer (Metrohm)., GMP, Validation, SOP, FDA, Quality System, GLP, Stability Analysis
Languages
Tamil
First Language
English
Advanced (C1)
C1
Timeline
SENIOR QA ASSOCIATE
NOVITIUM LABS PVT LTD
04.2024 - Current
Quality Control Analyst II
Teva Pharmaceutical Industries Ltd.
11.2013 - 04.2024
Master of Science (MSc) - Chemistry
MadrasChristian College
Bachelor of Science (BSc) - Chemistry
Madras Christian College
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