Job Title
Associate Manager – Microbiology
Company
Pfizer
Location
India – Vizag
Function
Quality Assurance and Control
Job Overview
The Associate Manager – Microbiology is responsible for ensuring microbiological quality compliance across pharmaceutical manufacturing and QC/stability laboratories. The role focuses on method validation, testing, investigations, and quality system adherence to ensure products meet regulatory and safety standards.
Key Responsibilities
1. Method Validation & Documentation
Create, review, and approve test method transfer and validation protocols
Review validation reports and equipment qualification records
Ensure compliance with GMP and internal quality standards
2. Microbiological Testing & Laboratory Operations
Perform microbiological testing including water, bulk, sterility, BET, and assay
Support media preparation and Bio-burden culture handling
Review laboratory data and ensure accuracy in reporting
Manage LIMS (Laboratory Information Management System) activities
3. Quality Compliance & Investigations
Maintain compliance with Current Good Manufacturing Practices (cGMP)
Conduct laboratory investigations and deviation analysis
Support CAPA (Corrective and Preventive Actions) and change control processes
Participate in safety inspections and audits
4. Cross-functional Collaboration & Training
Work with cross-functional QA, manufacturing, and regulatory teams
Participate in quality investigations and recommend corrective actions
Train and mentor junior team members
Contribute to continuous improvement initiatives
5. Regulatory & Documentation Support
Ensure adherence to regulatory guidelines and internal SOPs
Maintain accurate documentation for audits and inspections
Support compliance-related reporting and reviews
Required Qualifications & Experience
M.Sc. in Microbiology
8–10 years of relevant pharmaceutical industry experience
Strong expertise in microbiological testing (water, sterility, BET, assay)
Experience in method validation and laboratory investigations
Strong knowledge of pharmaceutical manufacturing and QA processes
Familiarity with CAPA, change management, and investigations
Strong attention to detail and quality mindset
Good communication and documentation skills
Preferred Skills
Experience in pharmaceutical QC/QA environment
Knowledge of LIMS systems
Data analysis and interpretation skills
Understanding of regulatory requirements (GMP, FDA, etc.)
Ability to train and mentor junior staff
Strong organizational and time management skills
Experience with AI tools for productivity improvement (e.g., ChatGPT, Copilot)
Work Environment
On-site role (Vizag facility)
Laboratory-based microbiology operations
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