Key ResponsibilitiesOperational Management
Oversee daily microbiological testing activities (environmental monitoring, water testing, raw materials, finished products, sterility testing, etc.).
Ensure timely testing, review, and approval of microbiology results.
Manage laboratory scheduling, workload distribution, and resource planning.
Compliance & Quality Systems
Ensure compliance with GMP, GLP, ISO, FDA, WHO, and other applicable regulatory standards.
Review and approve SOPs, protocols, test methods, and validation documents.
Lead microbiology-related deviations, OOS/OOT investigations, CAPAs, and change controls.
Team Leadership
Lead, train, and develop QC microbiology staff.
Conduct performance evaluations and competency assessments.
Promote a culture of quality, safety, and continuous improvement.
Audits & Inspections
Support internal, external, customer, and regulatory audits.
Prepare documentation and act as a subject matter expert during inspections.
Address audit findings and ensure timely closure of action items.
Method & Process Improvement
Evaluate and implement new microbiological methods and technologies.
Optimize testing processes to improve efficiency and compliance.
Ensure proper qualification, calibration, and maintenance of lab equipment.
Documentation & Reporting
Ensure accurate documentation, data integrity, and record retention.
Prepare and review trend reports, KPIs, and management summaries.
Monitor microbiological trends and recommend corrective actions.
Job Type: Full-time
Work Location: In person
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