As an experienced pharma Quality professional with about 12-year experience in the pharmaceutical industry, I have developed a strong understanding of regulatory requirements, analytical techniques and quality control principles. I am skilled in various techniques of laboratory analysis and compliance.
Overview
13
13
years of professional experience
Work History
TEAM LEADER (RM,PM and Sampling)
Emcure Pharmaceuticals limited
Visnagar
01.2024 - Current
Developing Specifications: Establishing and maintaining specifications for raw materials, packaging materials, finished products, intermediates, solvents, and reagents used in analyses.
Sampling and Testing: Overseeing the sampling and testing of raw materials and packaging materials to ensure they meet predefined specifications.
Documentation: Ensuring proper documentation of all QC activities, including test results, analysis reports, and compliance with regulatory standards.
Review and Release Procedures: Reviewing analyzed data and audit trails and implementing and managing release procedures to ensure that only materials meeting quality standards are approved for use.
QMS and Compliance: Ensuring ongoing QMS like Lab event and OOS/OOT compliance with regulatory requirements and internal quality standards.
Team Management: Leading and managing the QC team, providing training, and ensuring that all team members are qualified and competent to perform their tasks.
Problem Resolution: Addressing and resolving any quality issues that arise during the QC process.
REVIEWER
Zydus lifescienses ltd
AHMEDABAD
01.2018 - 12.2023
Data Review: Evaluating test data generated by QC analysts to ensure accuracy and compliance with specifications.
Audit Trails: Conducting audit trail reviews to verify that all QC activities have been properly documented, and that the data integrity is maintained.
Approval/Rejection: Making decisions on the approval or rejection of raw materials and packaging materials based on the test results, and compliance with standards.
Compliance: Ensuring that all QC processes and results comply with regulatory requirements and internal quality standards.
Documentation: Reviewing and approving QC documentation, including test reports, certificates of analysis (CoA), and other relevant documents.
Problem Resolution: Addressing any discrepancies or issues identified during the review process, and ensuring corrective actions are implemented.
SITE QUALITY CONTROL (SQC)
CIPLA Ltd.
Pithampur (Indore)
02.2016 - 09.2017
QUALITY CONTROL UNIT-IV
CIPLA Ltd.
11.2011 - 02.2016
Company Overview: Pithampur (Indore)
Analysis of Routine sample of RM / PM
(IR, UV, DSC, Water content, LOD, ROI)
Preparation of protocol and study of temperature and humidity distribution of reserve sample area
Review of analysis data of PM
Planning of RM / PM sampling
Pithampur (Indore)
Education
Bechler of Pharmacy - Pharmacy
Institute of Pharmacy
Ujjain
10-2011
Skills
SAP
LIMS
Track wise
Lab-solution
Tiamo 25
Cromaleon 72
Star-e
Rheocalc
Caromi (Pritmann)
Lab event
Change control
Reduce testing
Shade card /Artwork/ Specimen sample
Activities
Winner in the college cricket tournament held in IOP.
Winner in the college Chess tournament held in IOP.