Experience: Master’s degree in Microbiology/ pharmacy with 8-10 Years of experience in Microbiology Method Verification / Validation executions at Laboratory and Quality Review.

Core Competencies
- Microbiology Method Validation and Verification
- Change Control Management
- Quality Risk Management and Risk Assessment Tools
- Laboratory Equipment Qualification
- Regulatory Requirements and Compendial Compliance
- GMP Compliance and Data Integrity
- Investigation and Root Cause Analysis

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Technical Skills
- Demonstrated technical skills in method validation and testing like Bacterial Endotoxin Test (Gel Clot, Kinetic Turbidimetric, Kinetic Chromogenic methods) Sterility Testing (Membrane Filtration and Direct Inoculation)and Microscopic particulate count.
- Having experience in sterilization activities (Media Preparation and Growth Promotion Testing), Environmental Monitoring, Identification of Microorganism, Plate reading technique.
- Equipment Qualifications specifically Isolators, Incubators, MCS reader and Identification systems.
- Having knowledge on USP Chapters , , ,



, and EP and JP microbiological requirements
- Having Capability to understand the Compendial methods and review of analytical method validation data in accordance with ICH Q2 (R1/R2), USP, and EP standards.
- Interpretation of analytical systems generates data against the procedure requirements.
- Having capability to assess the test method requirements against USP, EP, BP, and JP requirements for Recent Product Introduction (NPI).
- Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
- Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.
- Knowledge of various Quality tools required for investigation

📌 Associate Manager-Quality Review (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam