Sona R

Quality Executive and Microbiologist with 2+ years of combined experience in pharmaceutical quality control and food, water, and environmental testing laboratories. Skilled in performing USP and IP-based enzyme assays, including Papain (Tyrosine Unit), Pancreatin, Alpha-Amylase, Trypsin, Lipase, Protease, and CoQ10 analysis. Experienced in stability studies, microbiological and chemical analysis, laboratory documentation, data validation, regulatory compliance, and audit support.

Possess working knowledge of GMP, GLP, HACCP, ISO standards, and FSSAI requirements, with a strong commitment to quality assurance and continuous improvement.

Pharmaceutical QA/QC Executive | Biochemist - Senthil Papain and Food Products Limited - Coimbatore, India

(2025-02)

• Executed Tyrosine Unit (TU) activity assays for Papain at various production stages, including latex homogenization, ultra-refined filtration, and final Ultra Refined Papain Powder (URPP) products. Monitored key physicochemical parameters, including pH, Total Soluble Solids (TSS), moisture, mineral content, clarity, and Sulphur Dioxide (SO₂), to ensure process control, product stability, and compliance with quality specifications.
• Performed USP-compliant enzyme activity assays for Pancreatin powder and pellet formulations, including Alpha-Amylase, Lipase, and Protease analysis, to evaluate enzyme potency and ensure compliance with pharmacopoeia and quality specifications.
• Conducted IP-based enzyme activity assays for Fungal Alpha-Amylase and Papain products, ensuring compliance with Indian Pharmacopoeia specifications through accurate analytical testing and documentation.
• Executed Coenzyme Q10 (CoQ10) assays using High-Performance Liquid Chromatography (HPLC), including sample and standard preparation, system suitability testing, chromatographic analysis, peak integration, result interpretation, and analytical documentation in accordance with approved analytical procedures.
• Conducted stability studies for enzyme products and finished formulations by performing routine analytical testing, monitoring quality parameters, evaluating product stability, and maintaining stability study documentation.
• Maintained GMP-compliant laboratory documentation, including analytical records, specifications, standard operating procedures (SOPs), logbooks, test reports, and quality control documentation.
• Assisted in internal audits by preparing quality records, supporting documentation reviews, and ensuring compliance with quality management system requirements.
• Collaborated with production and quality teams to monitor manufacturing processes, investigate deviations, implement corrective actions, and ensure adherence to product quality and regulatory requirements.
• Conducted USP-based Trypsin potency assays using spectrophotometric analysis of N-benzoyl substrate hydrolysis, ensuring analytical accuracy and compliance with quality standards.
• Conducted USP-based Pepsin potency assays by monitoring enzymatic digestion of egg white protein and calculating protein utilization to assess enzyme activity and product quality.

Quality Analyst | Food & Water Industry - Inventium Laboratories & Training Centre - Palakkad, India

(2024-10 - 2025-01)

• Perform microbiological, chemical, and physical analysis of food products, drinking water, and wastewater in accordance with established quality and safety standards.
• Conduct food testing on oils & fats, cereals, dairy products, fruits & vegetables, and nutritional parameters of raw materials as well as finished goods to ensure compliance with food safety requirements.
• Prepare, standardize, and validate reagents; ensure accuracy, traceability, and integrity of analytical data.
• Support implementation of HACCP-based systems, Good Laboratory Practices (GLP), and Good Hygiene Practices (GHP).

Master of Science - Microbiology - Bharathiar University (2024) Tamil Nadu, India

Bachelor of Science - Microbiology - Bharathiar University (2022) Tamil Nadu, India