With over 9 years and 3 months of experience in the pharmaceutical industry, I have specialized in Quality Control. Presently, I hold the position of Sr. Executive. Leading a finished product section with a team of 12 people. My responsibilities include monitoring and allocation of daily work in the QC lab and conducting analytical data review, investigating departmental Deviations, Lab incidents, OOS and OOT, and overseeing QMS activities like CAPA and change control.
Additionally, i manage Provide training to department personnel, conducting inter-departmental audits.
My expertise also extends to software's like LIMS Caliber, empower, chromeleon, Openlab EZ chrome.
I am dedicated to ensuring the highest quality standards in pharmaceutical operations.
1) Executed routine quality control department operations.
2) Conducted analysis of Finished Product (API), RM, and Intermediates.
3) Managed and calibrated analytical instruments including HPLC, GC, FTIR, UV Spectrophotometer, Autotitrator, and pH meter.
- Utilized HPLC, GC, FTIR, UV Spectrophotometer, Autotitrator, and pH meter for accurate analysis and calibration.
- Ensured precision in the analysis of Finished Product (API), RM, and Intermediates.
- Managed routine quality control department tasks with diligence and attention to detail.
1) Sampling and Analysis of Purifies water. 2) Sampling and Analysis of Finished Product (API) , RM , and Intermediates. 3) Handling of analytical instruments like HPLC, GC, FTIR, UV Spectrophotometer, Autotitrator, pH meter etc.
LIMS Caliber
Investigation
QMS
Good Team Leader & Team Player
Innovative and problem solving
Analytical Method Validation
Analytical Method Transfer
Analytical Review
Documents Review
Training Coordinator
Internal Auditor
9766754816
7875129977
Compliance activities through Quality Management Systems (Trackwise, Stratas oracle, software) like Change Control, Deviations investigations, OOS/OOT investigations CAPA assignments.
CAPA effectiveness check and preparation of investigation report.
Analytical Method Validation Protocol and report preparation for compendia and non-compendia Tests of API and Excipients.
Ensures Pharmacopeia compliance, EP,IP, JP,Ch.P, BP etc.
Audit preparation and explaining facts to inspectors during audits.(USFDA, TGA and customer audits)
Planning, monitoring and ensuring completeness of daily activity.
Review of laboratory records, instrument calibration records and all analytical data.
Laboratory Investigation of OOS, OOT, deviation and incident in the laboratory. and preparation of investigation report.
Ensuring that all activities carried out in the laboratory is in compliance with SOP’s and GLP.
Analytical Method Validation of new compendia and non-compendial analytical methods on HPLC and GC.
Calibration of instruments like HPLC, UPLC GC and maintaining record of Preventive Maintenance.
Troubleshooting of analytical instruments.
Conducting the training activity for new chemists with respects to SOPs and cGMP, maintaining records for same.
Additionally, I manage conducting inter-departmental audits.
LIMS Caliber
Empower
Chromeleon
Open Lab EZ
Trackwise Digital
Oracle