Ch. Srikanth

About Ch. Srikanth

Sterile injectable manufacturing professional with hands-on involvement in aseptic compounding, solution preparation, and sterile process execution in a regulated pharmaceutical manufacturing environment.• Direct experience in Installation Qualification (IQ) and Operational Qualification (OQ) of compounding vessels, transfer lines, filtration systems, and associated utilities in alignment with cGMP, EU GMP, and Annex 1 (2022) requirements.• Executed and supported CIP (Clean-in-Place) and SIP (Steam-in-Place) cycles, including verification of time, temperature, pressure, flow rate, and conductivity parameters as per validated protocols.• Performed Pre-use and Post-use Filter Integrity Testing (PUPSIT) using approved methods (Bubble Point / Diffusion / Pressure Hold) for sterile filtration processes.• Strong operational knowledge of Siemens PCS 7 SCADA and Batch systems, including recipe execution, phase logic, interlocks, alarm handling, and electronic batch record support.• Actively involved in batch manufacturing operations, ensuring strict adherence to approved BMRs, SOPs, and change control procedures.• Supported cleaning validation activities, including worst-case product selection, MACO calculations, residue acceptance criteria, and risk-based equipment grouping.• Contributed to preparation, review, and execution of cleaning validation protocols and reports for compounding vessels, filtration skids, transfer lines, and filling equipment.• Hands-on experience in sampling techniques for rinse, swab, and TOC analysis in support of cleaning validation and routine monitoring.• In-depth understanding of aseptic processing principles, including first air protection, unidirectional airflow, sterile connections, and interventions control.• Knowledge of cleanroom classification and qualification (Grade A/B/C/D), including non-viable and viable particle monitoring and trend evaluation.• Familiar with environmental monitoring programs, alert/action limits, excursion handling, and investigation support.• Understanding of Contamination Control Strategy (CCS) elements as per EU GMP Annex 1, including facility, equipment, personnel, and process controls.• Strong GMP documentation skills covering BMRs, qualification records, validation documents, deviations, CAPA, and logbooks.• Demonstrates disciplined GMP behavior, data integrity awareness (ALCOA+), and audit-ready documentation practices.

Experience

1. Manufacturing Executive

   Shantha Biologics Private Limited

   Dec 2024 — Present · Hyderabad, IN

Education

• Telangana state model school and junior college

  SSC

• Osmania University

  Bachelor of Science - BS, Chemistry

• Sardar Patel Education Institute

  Master of Science - MS, Organic Chemistry

• Board of Secondary Education, Telangana (BSET)

  Intermediate , Science