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 ManagementQuality Risk Management and Risk Assessment ToolsLaboratory Equipment QualificationRegulatory Requirements and Compendial ComplianceGMP Compliance and Data IntegrityInvestigation and Root Cause Analysis

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 <71>, <85>, <61>, <62>, <1116> and EP and JP microbiological requirementsHaving 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 New 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 investigationsTechnical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organizationKnowledge in change control assessmentBasic idea on manufacturing operations, validation and engineering functionsExperience in handling Regulatory agency inspections

Behavioral/Any Other Skills

Interpersonal Skills: Effective communication with all colleagues from different levels and builds constructive and effective relationshipManagerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.Acts Decisively: Makes decision in a timely manner based on available informationGrows Self: Identify Individual development needs and create a plan and work towards achieving those objectivesSelf-accountable & Proactive approachStrong scientific and analytical thinkingExcellent review and documentation skillsRegulatory and GMP compliance mindsetInvestigation and problem-solving capabilitiesCross-functional collaborationLeadership and mentoring skillsAttention to detail and data integrity focusEffective communication and stakeholder management  
Work Location Assignment: On Premise

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