Mallesha hl Mallesh

I am having 2 years of experience in the pharmaceutical company Quality Control department. Creative and quick learning, Professional highly committed to goal accomplishments, willing to accept responsibility, dedicated, hard-working, self-confidence and positive attitude and good communication skills. Ability to work as an individual and in team, confident in serving the best results in a goal oriented job.

Executive in Quality Control Department at Biocon biologics pvt Ltd (2024-05 – Present)

• Work in accordance with approved methods, SOPs and GMP/GLP, ALCOA and ALCOA+ while performing test.
• Involved in sampling of Raw materials and Packaging material.
• Conducted chemical and physical evaluations of raw materials and primary packaging materials as per validated test methods.
• Hands on Experienced in handling of analytical instruments Like UV-visible spectrophotometer, FTIR, Universal testing machine (UTM), Atomic absorption spectroscopy (AAS), HPLC etc.
• Monitored and recorded temperature and environmental conditions of laboratories, incubators, and walk-in chambers to ensure controlled conditions.
• Carried out sampling activities for raw material, packaging, consumable materials in line with SOPs and quality requirements.
• Hands on experienced in routine sample analysis with LIMS (Labware 7 Software).
• Managed sample lifecycle, test results, and documentation using LabWare LIMS, TrackWise, DMS, SAP, elog (Honeywell), Thermoclient, and PharmaMediTech systems.
• Provided support during routine inspections, customer audits, and internal quality audits by ensuring readiness of records and test data.
• Identified non-conforming packaging materials and initiated OOS documentation and investigations for deviations related to visual, dimensional, or specification failures.
• Aware about the QMS Flow and activities like OOS, Laboratory incidents and deviation etc.
• Ensured ongoing compliance with cGMP regulations (21 CFR Parts 210 & 211), GLP, GDP, and ICH quality guidelines across all laboratory activities.

M.Sc in Biochemistry – Banglore University (2024)

B.Sc in CBZ – Banglore University (2021)

PUC in PCMB – Department of Pre-University Education Karnataka (2018)

SSLC (2016)