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 , , , , 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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Quality Assurance and Control