Rupesh Kumar K.

About Rupesh Kumar K.

Experienced Analytical QC and Inhalation Testing professional with strong exposure to USFDA-regulated environments, specializing in nasal sprays, MDI, DPI, and inhalation dosage forms. Proven capability in generating, reviewing, and defending regulatory-compliant analytical data during internal, customer, and regulatory audits.Hands-on expertise in assay, dissolution, related substances, content uniformity, and physical characterization of finished and stability samples using HPLC/UPLC, UV, and wet chemistry techniques, strictly adhering to cGMP, GLP, ALCOA+, and data integrity principles.Extensive experience in inhalation and nasal device performance testing, including spray pattern, plume geometry, droplet size distribution (DSD), APSD, NGI, UDD, emitted dose, and shot weight, utilizing Malvern Spraytec/PSD & SprayView systems, automated actuators, and microscopy—with full traceability and audit-ready documentation.Actively involved in trend analysis, OOS/OOT/PNC/LIR investigations, root-cause analysis, and timely escalation in line with USFDA expectations. Well-versed in reviewing audit trails, message centers, electronic records, and CDS/LIMS entries to ensure compliance with 21 CFR Part 11.Strong experience in method development, optimization, validation, and transfer, including impurity and degradation product profiling to support product safety, efficacy, and shelf-life claims. Conducted stability studies under various ICH conditions (temperature, humidity, orientation) with accurate data interpretation and reporting.Technically proficient in HPLC (Waters, Shimadzu 2010/2030/Arc), UPLC, LC-MS, UV-Visible, FTIR, KF, Auto Titrator, Dissolution, pH meter, Polarimeter, and Analytical Balance, including instrument calibration, qualification support, and maintenance as per SOPs.Demonstrated strength in GDP-compliant documentation, reagent and standard management, sample reconciliation, chemical inventory control through LIMS, and readiness for USFDA inspections, mock audits, and regulatory queries.

Experience

1. Team Member

   Dr. Reddy's Laboratories

   Dec 2023 — Present · Pydibhemavaram, IN

   Analytical Testing: Performing a wide range of physical, chemical, and potentially tests on nasal spray formulations and devices. Formulation Analysis: Testing properties such as pH, viscosity, osmolality, surface tension, and the content uniformity of active ingredients and excipients. Device Performance: Evaluating pump delivery (shot weight), spray pattern, plume geometry, droplet size distribution (DSD), and emitted dose using specialized equipment like automated actuators, SprayView systems, and Malvern Spraytec instruments. Stability Studies: Conducting stability testing under various conditions (temperature, humidity, orientation) to assess product integrity and ensure shelf-life claims. Impurity and Degradation Product Analysis: Identifying and quantifying impurities and degradation products that may affect product safety and efficacy. Method Development and Validation: Developing, optimizing, and validating analytical methods for characterizing nasal spray products and their components. Quality Control (QC): Performing routine QC testing to ensure that manufactured products meet established quality standards and regulatory requirements, Technical Skills:Proficiency in operating and maintaining analytical instrumentation, including HPLC,UPLC, LCMS, laser diffraction systems, and other specialized equipment for nasal spray analysis.

Education

• Chhattisgarh Swami Vivekanand Technical University

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences

  2014 — 2018

• College of pharmaacy

  Bachelor of Pharmacy - BPharm, Pharmaceutics and Drug Design