Hirenkumar Prajapati

• As a Quality Control Executive, I have been responsible for ensuring that all products manufactured meet the highest quality standards, are in compliance with all regulatory requirements, and are safe for use by patients. I have a solid understanding of Good Manufacturing Practices (GMP) and have experience in implementing and maintaining quality management systems. Expertise in conducting product testing, analyzing data, and identifying quality issues has enabled me to identify potential issues and take corrective action in a timely manner. I have experience in managing laboratory operations, ensuring equipment and supplies are properly maintained and calibrated, and have experience in managing a team of laboratory technicians. My experience also includes liaising with regulatory authorities and ensuring compliance with relevant laws and regulations, including FDA regulations. I have experience in preparing and submitting regulatory filings, conducting audits, and ensuring that all documentation is accurate and up-to-date. Academically, I completed a full-time Bachelor of Science in Biotechnology in the year 2008. Following which, I pursued my Master of Science in Biotechnology in the year 2010.

• I would like to highlight my job duties as a Sr. Executive- Quality Control Dept. at Sun Pharmaceutical Medicare Limited (Transferred from Unimed Technologies Ltd.) that I have been performing there since April 1, 2021 

• 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.
• Actively participates in method transfer activities between facilities within the   organization or between organizations.
• Perform analytical process validation and maintain test data and documentations in accordance with SOP, cGLP, cGMP and ICH requirement.
• Assist with the development and execution of the company's overall quality strategy.
• Ensure compliance with all applicable regulations industry standards related to quality control.

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.

(1) 2010

Ganpat University, Gujarat

Master of Science in Biotechnology

(2) 2008

Hemchandracharya North Gujarat University

Bachelor of Science in Biotechnology