Tejaswini Somashekar

QC Executive with 4+ years of experience in Labware LIMS configuration, workflow optimization, and regulatory compliance. Proven expertise in QMS, deviation/OOS/OOT, CAPA, change control, risk assessment, data integrity (ALCOA+), and audit readiness. Adept at ensuring regulatory compliance with FDA, EMA, and ISO standards while supporting cross-functional teams in quality assurance and process improvement.

Proven ability to streamline documentation workflows, enhance accuracy, and support successful inspections. Strong communicator with a focus on operational excellence, continuous improvement, and maintaining high standards of product quality and safety. Hands-on experience in instrumentation troubleshooting and qualification, TOC, KF, IR and titration systems.

Proficient in LIMS, SAP, and Veeva Vault(Basic).

Executive – QC Insulin (Analyst) at BIOCON BIOLOGICS LTD. (2021-11 – Present)

• Performed IR, TOC, Specific optical rotation, Melting point, Karl Fischer, potentiometric titrations, and polarimetry testing.
• Conducted pharmacopeial testing per USP/EP/IP; executed method validation and system suitability studies.
• Serve as LIMS Superuser; responsible for static data creation and modification. Developed and implemented QA template calculations in LIMS, significantly reducing manual calculation errors.
• Actively support internal and external audits by ensuring rigorous documentation and full adherence to compliance standards.
• Lead and contribute to 5S initiatives and Kaizen programs; recognized for innovative process efficiency ideas.
• Manage non-routine activities including logbook issuance, data archival, and submission of documents monthly for QA archival.
• Maintain comprehensive chemical inventory control, including receipt, verification, and safe disposal protocols for expired materials.
• Coordinate with vendors for timely material procurement, verification, and reconciliation. Ensure smooth communication channels to resolve discrepancies and maintain uninterrupted supply.
• Oversee batch release activities by aligning material availability with production schedules, ensuring compliance with QA standards, and minimizing delays.
• Work closely with production, QA, and procurement teams to streamline workflows, enhance traceability, and ensure end-to-end compliance.
• Track material usage trends, anticipate shortages, and implement proactive measures to optimize resource allocation.
• Enforce strict adherence to safety protocols during material handling, storage, and disposal, ensuring compliance with regulatory requirements.

M.Sc. in Organic Chemistry – Bangalore University (2017-01 – 2019-12)

B.Sc. in Chemistry – NMKRV College (2014-01 – 2017-12)