Pfizer

Associate Manager-Quality Review (BQ)

Posted 3 Days Ago

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead and review microbiology method validation/verification and quality activities including BET and sterility testing, equipment qualification, change control, risk assessments, investigations, regulatory/GMP compliance, documentation review, and cross-functional mentoring to support product lifecycle and inspections.

Summary Generated by Built In

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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Master's degree in Microbiology or Pharmacy with 8-10 years of experience in Microbiology Method Verification/Validation and Quality Review
Practical experience executing microbiology method validation/verification including Bacterial Endotoxin Test (Gel Clot, Kinetic Turbidimetric, Kinetic Chromogenic)
Experience with sterility testing methods (membrane filtration and direct inoculation) and microscopic particulate count
Experience in sterilization activities, media preparation, growth promotion testing, environmental monitoring, and microorganism identification
Hands-on knowledge of equipment qualification (isolators, incubators, MCS reader, identification systems) and laboratory equipment qualification practices
Knowledge of USP/EP/JP/BP compendial requirements and ability to assess compendial methods for New Product Introduction
Ability to review analytical method validation data per ICH Q2 (R1/R2), USP, and EP standards
Knowledge and application of ICH Q9 Quality Risk Management and change control assessment
Understanding of validation principles for process, cleaning, analytical method validation, water systems, HVAC, equipment and utility qualifications
Experience conducting investigations, root cause analysis, and using quality tools for investigations
Strong technical writing skills for accurate, concise, compliant documentation
Experience handling regulatory agency inspections
GMP compliance mindset, data integrity focus, and excellent review/documentation skills
Interpersonal, managerial, leadership and cross-functional collaboration skills; ability to mentor and make timely decisions

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
Retirement Support — A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
Leave & Time Off Breadth — Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.