To establish, maintain, and monitor microbiological quality systems for medical disposable products, manufacturing areas, utilities, and laboratory activities in compliance with ISO 13485, GMP, customer requirements, and applicable regulatory standards.
Key Responsibilities
1. Microbiological Testing
Perform bioburden testing of finished and in-process products.
Conduct microbial limit testing as applicable.
Perform sterility testing according to approved procedures.
Analyze and interpret microbiological test results.
Prepare microbiological reports and maintain records.
2. Environmental Monitoring
Conduct routine environmental monitoring of manufacturing and controlled areas.
Air sampling monitoring.
Surface monitoring and swab testing.
Personnel monitoring.
Trend environmental monitoring results and identify risks.
3. Water System Monitoring
Perform microbiological testing of purified water and process water.
Monitor water quality trends.
Investigate out-of-specification results.
Recommend corrective actions.
4. Laboratory Management
Maintain microbiology laboratory equipment.
Ensure calibration and preventive maintenance of laboratory instruments.
Monitor culture media preparation and qualification.
Maintain laboratory inventory and consumables.
5. Documentation & Compliance
Prepare and revise SOPs.
Maintain test records and laboratory logbooks.
Ensure compliance with ISO 13485 requirements.
Support internal and external audits.
Maintain data integrity and traceability.
6. Investigation & CAPA
Investigate microbial contamination incidents.
Perform root cause analysis.
Prepare CAPA reports.
Verify effectiveness of corrective actions.
7. Validation Activities
Support cleaning validation.
Support sterilization validation.
Support process validation activities.
Participate in risk assessments.
8. Training
Train production staff on:
Personal hygiene
Gowning procedures
Cleanroom practices
Contamination control
Required Qualifications
Education
B.Sc. Microbiology (Minimum)
M.Sc. Microbiology (Preferred)
Experience
2–5 years experience in:
Medical Device Industry
Pharmaceutical Industry
Healthcare Products Manufacturing
Technical Knowledge
ISO 13485
GMP
GLP
Sterility Assurance
Environmental Monitoring
Bioburden Testing
CAPA
Risk Management
Key Performance Indicators (KPIs)
Quality KPIs
Environmental monitoring compliance: ≥98%
Testing completed within schedule: ≥95%
No critical microbiological audit observations.
Timely closure of CAPA: ≥95%
OOS investigations closed within 30 days.
Documentation KPIs
SOP review compliance: 100%
Laboratory records accuracy: 100%
No data integrity violations.
Training KPIs
Staff training completion: 100%
Hygiene compliance score: ≥95%
Audit KPIs
Internal audit observations closed on time.
Regulatory audit readiness maintained throughout the year.
Authority
The Microbiologist has authority to:
Stop release of microbiologically non-conforming materials.
Raise deviation reports.
Recommend CAPA actions.
Escalate contamination risks to management.
Confidentiality Requirements
The employee shall maintain strict confidentiality regarding:
Product specifications.
Manufacturing processes.
Validation protocols.
Customer information.
Regulatory documentation.
Pricing and commercial information.
Supplier information.
Unauthorized disclosure may result in disciplinary action including termination and legal proceedings.