Associate Manager-Quality Review (BQ)

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

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 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 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 investigations
• Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization
• Knowledge in change control assessment
• Basic idea on manufacturing operations, validation and engineering functions
• Experience in handling Regulatory agency inspections

Behavioral/Any Other Skills

• Interpersonal Skills: Effective communication with all colleagues from different levels and builds constructive and effective relationship
• Managerial 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 information
• Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
• Self-accountable & Proactive approach

• Strong scientific and analytical thinking
• Excellent review and documentation skills
• Regulatory and GMP compliance mindset
• Investigation and problem-solving capabilities
• Cross-functional collaboration
• Leadership and mentoring skills
• Attention to detail and data integrity focus
• Effective communication and stakeholder management

  
Work Location Assignment: On Premise

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