Souradwip Biswas

Post Graduate Associate at Qc - Invitro @Biological E. Limited

Hyderabad, IN

Vaccine QC Testing: Involved in in-process, intermediate, bulk, and final lot testing of Hepatitis B vaccines.🧪 Analytical Testing (Hepatitis B Vaccine): Performed key assays such as- Purity by SDS-PAGE - Thiomersal content - Protein estimation (Lowry method)- Lipid and carbohydrate content - pH and description - In-vitro potency - Percent adsorption (Sandwich ELISA) Reagent & Solution Preparation: Responsible for preparing critical reagents and buffers used in QC assays to ensure accuracy and repeatability. Documentation: Maintained precise and compliant records in LCRs and Test Request Forms (TRFs). LIMS Operations: Efficiently managed sample tracking and data entry using the Laboratory Information Management System (LIMS).🧪 Inventory & Stock Management: Verified QC inventory, ensured timely disposal of expired chemicals and consumables.🧠 Training & LMS Compliance: Actively participated in internal training programs and maintained up-to-date compliance through the Learning Management System (LMS). Equipment Calibration & Maintenance: Coordinated routine calibration, validation, and maintenance of laboratory instruments.🧬 Method Validation & Standards: Supported analytical method validation and established in-house reference standards for vaccine assays.🧾 Regulatory Compliance: Ensured adherence to GMP, GDP, and SHE (Safety, Health & Environment) guidelines. Investigative Support: Contributed technical input and documentation during deviations, investigations, and CAPA processes.