A responsible and challenging position that will allow me to explore my capabilities, skills and sense of dedication towards my duties with the aim of seeing the progress of the organization.
Overview
17
17
years of professional experience
2
2
Languages
Work History
Deputy Manager
Dr. Reddy's Laboratories Ltd.
10.2021 - Current
Responsible for overseeing the handling of OOS, OOT and deviations with collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports.
Responsible the periodically assessing the trending of deviations, highlighting or escalating key observations, regularly reviewing the SAP incident log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports.
Participating in review meetings with the team to discuss about the progress of projects as well as for identifying gaps and suggesting effective solutions for the same along with controlling all release & planning activities & reviewing document.
Contributed to team success by completing jobs quickly and accurately.
Active participation in scientific discussions and represent quality operations in different forums.
Coordinating Safety Health & Environmental assessments of new chemicals and reagents for the laboratory testing lab.
Executive
Mylan Laboratories Ltd.
06.2015 - 08.2017
Immersed in Chromatographic Analysis samples of finished and Bulk.
Performing the Assay and Related Substance as with using HPLC methodology.
Calibration of instruments like HPLC.
Developed and executed SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.
Maintained Instrument Logbooks and Instrument Calibration Records & HPLC Systems.
Executive
Ipca Labs Limited
09.2014 - 05.2015
Monitored the progress of a group of reviewers for the review of routine analyses and exhibit batches, on-line, and complete the review for release.
Performed as analyst for understanding of Empower3 and Chromeleon software, system awareness which where newly installed in QC.
Managed Out of Specification, Out of Calibration, Out of Trend.
Monitored Calibration activities for daily calibration & scheduled calibration Instrument with review of documents.
Immersed in Data Reliability Review and Maintain the Compliance as per SOP.
Management Staff
Cipla Ltd.
04.2010 - 08.2014
Chromatographic Analysis samples of finished and Bulk.
Performing the Assay and Related Substance as with using HPLC methodology.
Calibration of instruments like HPLC.
Officer
Akums Drugs & Pharma Ltd.
12.2008 - 04.2010
Sampling of Raw material & excipient of Penicillin and Cephalosporin.
Performing the water content analysis with using KF-Titration methodology.
Performing the dissolution analysis with using Dissolution apparatus & UV-Spectrophotometer.
Maintained a clean work environment adhering to all relevant local regulations ensuring high-quality compounding processes.
Education
Master of Science - Chemistry
Shobhit University
Meerut, India
04.2001 -
Skills
Proficient in diagnosing analytics problems
Computer Profile
MS Office
Excel
LabWare LIMS V-7.0.2i
SAP Logon 760
Area Of Excellence
Data Capturing & Documentation
Team Management & Leadership
Lab Operations
Calibration & Troubleshooting
Current Job Responsibility - Key Result Areas
Responsible for overseeing the handling of OOS, OOT and deviations with collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports.
Responsible for periodically assessing the trending of deviations, highlighting or escalating key observations, regularly reviewing the SAP incident log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports.
Participating in review meetings with the team to discuss about the progress of projects as well as for identifying gaps and suggesting effective solutions for the same along with controlling all release & planning activities & reviewing document.
Active participation in scientific discussions and represent quality operations in different forums.
Coordinating Safety Health & Environmental assessments of new chemicals and reagents for the laboratory testing lab.
Instrument Profile
HPLC, as Chromatography with Empower-3 and Chromeleon software
Dissolution, UV-Spectrophotometer and Disintegration rate as drug release
Audits Faced
USFDA
MHRA
TGA (Australia)
WHO GMP
MCC (South Africa)
Function Competencies
Proficiency in troubleshooting problems for analytics.
Advanced computer skills and experience with MS software application.
Knowledge of Good manufacturing practices and Good Laboratory practices.
Behavioral Competencies
Quality mind-set with right first time approach.
Proactive approach, focusing on prevention than detection.
Analytical thinking, problem solving and decision making.
Able to work independently and Man power management.
Networking skills, able and willing to work in a global environment.
Accuracy and commitment to timeframes.
Disclaimer
I hereby declare that all the above particulars are true to the best of my knowledge and belief.
Personal Information
Father's Name: Mr. Anand Pal
Marital Status: Married
Permanent Address:
494- South Bhopa Road-3, New Mandi, Muzaffarnagar, 251001
Associate Director -Strategy & PMO, Marketing at Dr Reddy's Laboratories LtdAssociate Director -Strategy & PMO, Marketing at Dr Reddy's Laboratories Ltd