Jitendra Kumar Email & Phone Number

Experienced Quality Control Manager (>20yrs) with a demonstrated history of working in the pharmaceutical industry. Committed to ensuring product quality, compliance, and adherence to current Good Manufacturing Practices (cGMP). Skilled in a wide range of analytical techniques, instrument qualification, and analytical method development, verification, and validation.Experience: Quality Control Manager | [DEC Pharmaceutical NZ Ltd] [2003-Present]• Manage all aspects of the quality control operations in a highly regulated pharmaceutical facility.• Oversee a team of dedicated professionals to ensure accurate and efficient quality control processes.• Develop and implement quality control procedures and protocols in compliance with cGMP regulations.• Successfully navigate and contribute to three yearly FDA audits, maintaining compliance with regulatory requirements.• Employ advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC/UPLC), UV/Vis Spectroscopy, FTIR/NIR Spectroscopy, Dissolution techniques, and other laboratory instrumentation for comprehensive pharmaceutical analysis.• Qualify and validate laboratory instruments to ensure accurate and reliable measurements.• Develop and validate spreadsheets in accordance with 21 CFR Part 11 guidelines for data integrity and electronic recordkeeping compliance.• Collaborate with cross-functional teams, including R&D, Manufacturing, and Quality Assurance, to drive continuous improvement initiatives and enhance overall product quality.Education:• Certificate in Quality Assurance | [New Zealand Organisation of Quality]• Post-Graduate Diploma in Physics and Mathematics | [University of the South Pacific]• BSc. Physics and Mathematics| [University of the South Pacific]Skills:• cGMP Compliance• HPLC/UPLC Method Development and Validation• UV/Vis Spectroscopy• FTIR/NIR Spectroscopy• Melting Point Apparatus• Polarimetry• TLC• Instrument Qualification• Spreadsheet Development and Validation (21 CFR Part 11 Compliant)• Analytical Method Development, Verification, and Validation• Regulatory Audits (FDA)As a highly skilled Quality Control Manager, I am dedicated to ensuring the highest level of quality, accuracy, and compliance within the pharmaceutical industry. With a strong background in cGMP, analytical chemistry, and regulatory requirements, I am well-equipped to lead and optimize quality control operations. Let's connect and discuss how I can contribute to the success of your organisation.

Listed skills include Physics, Chemistry, Hplc, Analytical Chemistry, and 9 others.