Associate Manager - Quality Control
Location: Visakhapatnam (Vizag), India
Employment Type: Full-Time
Company: Pfizer
Position Summary
The Associate Manager - Quality Control is responsible for ensuring laboratory compliance, method validation, microbiological testing, and quality control operations within pharmaceutical manufacturing environments. The role supports analytical testing, stability programs, laboratory investigations, equipment qualification, and continuous quality improvement while maintaining compliance with cGMP and regulatory standards.
Key Responsibilities
Quality Control Operations
Create, review, and approve method transfer protocols and validation reports.
Review and approve equipment qualification documentation.
Ensure compliance with Current Good Manufacturing Practices (cGMP) in QC and Stability laboratories.
Review laboratory records, testing results, and analytical data.
Microbiology & Laboratory Testing
Support media preparation and BioBall culture handling activities.
Perform microbiological testing of water and other samples.
Conduct microbiology-related investigations and root cause analysis.
Monitor environmental and laboratory testing activities.
Laboratory Systems & Data Management
Manage Laboratory Information Management System (LIMS) builds and updates.
Review laboratory-generated data for accuracy and compliance.
Maintain laboratory documentation and records.
Ensure data integrity and regulatory compliance.
Quality Compliance & Investigations
Participate in deviation investigations and quality assessments.
Recommend corrective and preventive actions (CAPA).
Conduct laboratory safety inspections and compliance reviews.
Support audit readiness and regulatory inspections.
Leadership & Cross-Functional Support
Serve on cross-functional teams supporting manufacturing and quality initiatives.
Train and mentor junior analysts and laboratory personnel.
Support continuous improvement and operational excellence programs.
Collaborate with QA, Manufacturing, Validation, and Regulatory teams.
Educational Qualification
Master's Degree in Sciences, Pharmacy, Microbiology, Biotechnology, Chemistry, or related field with 5-7 years of experience.
OR
Bachelor's Degree in Sciences, Pharmacy, Microbiology, Biotechnology, Chemistry, or related field with 6-8 years of experience.
Experience Required
5-8 years of pharmaceutical Quality Control experience.
Experience in method validation and analytical testing.
Experience in microbiological testing of water systems.
Strong exposure to pharmaceutical manufacturing and quality systems.
Experience with laboratory investigations and CAPA management.
Experience using LIMS platforms preferred.
Technical Skills
Quality Control Operations
Method Validation
Method Transfer
Analytical Testing
Microbiological Testing
Water Testing
Environmental Monitoring
Stability Studies
Laboratory Investigations
Equipment Qualification
Data Integrity
CAPA Management
Root Cause Analysis
Risk Assessment
cGMP Compliance
Laboratory Documentation
Regulatory Compliance
Audit Readiness
LIMS Administration
Software & Systems
Laboratory Information Management System (LIMS)
Microsoft Excel
Microsoft Word
Microsoft PowerPoint
Data Analysis Tools
Quality Management Systems (QMS)
Core Competencies
Quality Management
Analytical Thinking
Problem Solving
Attention to Detail
Decision Making
Team Leadership
Cross-Functional Collaboration
Communication Skills
Time Management
Investigation Management
Training & Mentoring
Continuous Improvement
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