Senior Executive – Quality control Department at Drug Manufacturing company (2022-04 – Present)
- Monitoring a group of analysts and sample management of In-process and Finished Products
- Coordinating with core functional team like QC, QA, R&D, Production and Regulatory Affairs team for the successful release of product
- Maintain proper documentation associated with the preparation and review of analytical specifications and raw data sheets, Analytical method validation, method verification documents
- Daily audit trial verification Empower software and Open lab software
- Qualification of Alternative vendor Active Pharmaceutical Ingredients
- Provides guidance to junior members on GLP and analytical techniques (through team meetings and individual interactions)
- Maintain cGMP, GLP and Notebook keeping to satisfy regulatory affairs
- Conducts approvals/rejection of finished products and In-process samples
- Stability studies for ANDA Products and Compilation of stability data
- Review & approval of SOPs, STPs / Specifications
- Finished products Hold time study In process and Process Validation samples allocation to group members
- Preparation of certification of analysis (COA) for finished products
- Calibration of analytical instruments such as HPLC, GC, IR, UV, and KF
- Maintain entire quality control operations ensuring quality parameters for the tablets, capsules, suspensions, dry powder and injectable dosage forms
- Indenting Chemicals, Columns, Reference standards (USP/EP) and Impurity standards and follow up
- Interacting with other departments for review, evaluation and proper closure of deviation, incidents, CAPA, OOS, OOT and change control
- Highly experienced with HPLC troubleshooting and maintenance
- Regular lab maintenance and daily work scheduling, Ensuring Safety compliance in lab
- Responsible for charging and withdrawal of stability samples and maintenance of stability chambers
- Successful Coordination for the various audits like US FDA, EDQM, MHRA and Customer audits
- Preparing the training modules based on the review outcomes and conduct training to the quality control personnel to improve laboratory compliance
Analytical Scientist-II – Analytical Method Validation Department at Aurobindo Research Center-I (2016-04 – 2022-04)
Executive – Quality control and validation at Graviti pharma (2014-02 – 2016-03)
Analyst – Quality control and R&D at Zenara pharma (2011-07 – 2014-02)
