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.
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
Technical Skills
Behavioral/Any Other Skills
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
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
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