Siva Rami Reddy Chitte

Professional Summary:

With over 13 years of experience in Extractables and Leachables studies, finished products, validations, and raw materials within analytical departments. Expertise in analytical testing and quality control. Developed a comprehensive skill set that effectively contributes to the success of organizations. Aspiring to contribute to a forward-thinking organization by taking on a challenging role that encourages continuous learning and growth. Strong foundation in analytical chemistry and a proven track record in utilizing advanced technologies. Aim is to deliver impactful solutions that drive organizational success and innovation.

LCMS/MS:

Waters LC-MS/MS, Mass Lynx, Agilent LCMS/MS 6495, Mass Hunter, Shimadzu LCMS/MS 8060NX, Lab Solutions DB Version,

GCMS/MS:

Agilent 5977A, Mass Hunter, Shimadzu 8050NX, Lab Solutions DB Version,

ICP-MS: Agilent 7900, Mass Hunter,

HPLC:

Waters 2695, Empower 3, Agilent 1260, Chromeleon, Waters Acquity, Empower 3,

SHIMADZU, 1800, Perkin Elmer, Electro lab Manual & Auto Sampler

• Expertise in extractable-leachable testing of various pharma dosages and packaging materials, including injectables, topicals, ophthalmic, OINDPs and other CCS.
• Ensured adherence to regulatory guidelines such as USP and , ISO 10993-18, and FDA requirements, facilitating successful product approvals.
• Developed and optimized analytical methods for the reliable identification of SVOC, VOC, NVOC, EI and quantification of extractables, contributing to effective risk mitigation strategies and enhancing overall product safety.
• Evaluated the compatibility of packaging materials and medical devices with drug formulations, to maintain product quality.
• Analyzed data to provide insights for regulatory submissions, facilitating timely product launches.
• Nitrosamines and Genotoxic impurities testing by using LSMS/MS, GCMS/MS.
• Performed analytical method validations, verifications, development, and feasibility studies by using LCMS, GCMS & GC-HS, UPLC, HPLC.
• Involved in technology and method transfers.
• Preparation and review of Method validation and verification protocols and Reports.
• Analysis of Related substances, purity, Assay, and content of uniformity by HPLC.
• Having good experience in complete analysis of finished products, in process samples and Raw materials.
• Complete analysis of Oral solid dosage forms (Tablets & Capsules) and Injectables.
• Carrying out calibrations of the instruments used in laboratory.
• Maintaining and performing activities as per GLP and cGMP.

• Best Performer Award for Achieving Revenue Targets
• Best Team Award for Reaching Milestones

• Father's Name: Ch. Srirami Reddy
• Mother's Name: Ch. Ramalaxmamma
• Date of Birth: 08/05/90
• Gender: Male
• Marital Status: Married

I hereby declare that the above information that has been provided is true to the best of my knowledge.