Sr. Executive- Quality Control Dept. | Apr 1, 2021 – Present | Sun Pharmaceutical Medicare Limited (Transferred from Unimed Technologies Ltd.)
- Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
- Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes. Creates and maintains laboratory record documentation (notebooks and computer-based), documents -exact steps followed during analysis execution, calculates and reports results in a timely manner.
- Perform analytical process validation and maintain test data and documentations in accordance with SOP, cGLP, cGMP and ICH requirement.
- Develop and validate new methods for the analysis of raw materials, in-process samples, and finished products.
- Assist with the development and execution of the company's overall quality strategy, including setting goals, creating budgets, and allocating resources.
Executive | Mar 26, 2017 – Mar 31, 2021 |
Sun Pharmaceutical Medicare Limited (Transferred from Unimed Technologies Ltd.)
Officer - Quality Control | Jun 1, 2016 – Mar 25, 2017 | Unimed Technologies Limited
Combined roles for two designations:
- Managed day-to-day quality control operations, oversee the work of quality control personnel, and develop and implement quality control policies and procedures.
- Conducted inspections of products and materials to ensure compliance with quality standards and regulations, and identify and document any defects or non-conformities.
- Perform analytical process validation and maintain test data and documentations in accordance with SOP, cGLP, cGMP and ICH requirement.
- Tested, analysed, developed and maintained quality control databases and documentation, and work with cross-functional teams to identify and resolve quality issues.
- Calibrated laboratory equipment, performed troubleshooting, trained new employees and perform multiple assignments.
Officer - Quality Control Dept. | Jul 13, 2015 – May 30, 2016 |
Amneal Pharmaceuticals Company (I) Pvt. Ltd.
Senior Chemist | Apr 1, 2014 – Jul 7, 2015
Technical Supervisor- QC | Mar 15, 2012 – Mar 31, 2014
Cadila Healthcare Limited
Combined roles for three designations:
- Oversaw quality control procedures and ensured adherence to company standards.
- Followed current USP/NF methods for the identification and analysis of raw materials.
- Ensured compliance with FDA and ISO standards by conducting regular audits, training team members on regulatory requirements, and implementing process improvements as needed.
- Prepared and standardized stock test, volumetric, and buffer solutions, as well as HPLC mobile phases, on a regular basis.
- Adapted to numerous changes in laboratory organization, including implementation of 6S and shift to paperless data entry via Caliber LIMS.
- Performed residual solvents analysis with GC using the Chromeleone Software.
- Identified and assayed raw pharmaceutical materials according to a variety of USP protocols, including viscosity, residue on ignition, trace heavy metals, and Karl Fischer titration.
- Utilized Potentiometer using the Tiamo Software for various analyses on raw materials. Conducted analysis using UV/Vis, FTIR, Karl Fisher titrator, and Polarimeter.
