S Mohankumar

B. Pharm graduate with around 7 years of experience in Quality Control at OneSource Specialty Pharma Limited, having worked with Caplin Steriles Limited and Micro Labs Limited. Expertise in the review of analytical testing, analytical method validation, method verification, and method transfer documentation for sterile injectables, beta-lactam dry powder formulations, and oral solid dosage forms, with strong analytical knowledge of wet chemistry techniques and instrumental analytical techniques.

Proven ability to support and successfully handle regulatory audits from the USFDA and CDSCO while adhering to industry best practices and regulatory standards, ensuring compliance with 21 CFR, cGMP, and safety requirements. Seeking a challenging position in Quality Control and Analytical Quality Assurance, with opportunities to contribute to analytical compliance, quality systems, and continuous improvement.

Executive- Quality Control - OneSource Specialty Pharma Limited - Bengaluru, India

(2024-06)

• Responsible for the review of finished products, raw materials, and stability samples analytical data for accuracy, completeness, and preparation of Form-39 Test certificate (COA).
• Prepare and review analytical method validation, verification, and transfer protocols, and reports.
• Preparing SOPs, URS, QRM, Change Control documents, and LIMS product preparations.
• Handling & Supporting the investigation of quality events (deviations, OOS, OOT), assisting with root cause analysis, and contributing to corrective and preventive actions (CAPAs).
• Coordinating and managing document control processes, including SOPs, protocols, and work instructions.
• Maintaining all analytical equipment, instruments, chemicals, and standards in QC.
• Supporting the qualification and maintenance of controlled environments, equipment, and instruments in collaboration with QC and engineering teams.
• Review of QMS, change control in Trackwise, and documents in EDMS as per requirement.
• Manage the installation, calibration, and routine use of analytical instruments and laboratory systems.
• Contribute to project management efforts within the QC function, identifying opportunities for process improvement and efficiency.
• Conducted and reviewed CSV protocols for OQ and PQ for new instrument qualification in eValgenesis, and executed instrument qualifications, like OQ and PQ, in e-Valgenesis.
• Responsible for coordinating with the Engineering and Maintenance team, as well as external vendors, for instrument qualification, preventive maintenance, and calibration activities.

Executive - Caplin Steriles Limited - Tiruvallur, India

(2022-04 - 2024-06)

• Analyzing the Raw Materials, Finished product and Stability samples.
• Performing tests such as Assay by UPLC and ICP-MS and Potentiometry.
• Preparation and execution of Analytical Method Validation, Verification, Transfer protocol, reports.
• Timely calibrated analytical instruments such as ICP-MS, UPLC, AAS, UV, Viscometer, Autotitrator.
• Dissolution (Type-IV).
• Water Content by KF and Coulometer.
• Identification, content (EI) by ICP-MS and AAS.
• Particles Size analysis (PSD) by Malvern Mastersizer.
• Volumetric Solutions Preparation and Standardization.
• Performing tests such as LOD, Sulfated ash, Hydroxyl value, Iodine value.
• Packaging Material Analysis such as Grammage, Dimension, Penetrability and Bursting Strength.

Executive - Microlabs Limited - Hosur, India

(2019-07 - 2022-04)

• Analyzing the Inprocess and Finished product samples and sampling of RM, PM.
• Performing tests such as Average weight, Friability, Disintegration, Identification by IR.
• Identification and Assay by UV, Dissolution (Type -I & II) By UV.
• Process validation analysis such as Blend uniformity, Dissolution by UV.
• UOD by CU and Weight variation.
• Assay by Potentiometry, Water Content.
• Timely calibrated analytical instruments such as pH Meter, Analytical Balance, UV, Dissolution.

Bachelor of Pharmacy - Pharmacy - The Tamilnadu Dr. M.G.R Medical University, Adhiparasakthi College of Pharmacy