Microbiologist

Microbiologist – Shri Durga Surgical

Position Details

Designation: Microbiologist / QC Microbiologist

Department: Quality Assurance & Quality Control

Reporting To: QA Manager / Plant Head / Director

Location: Shri Durga Surgical

Job Purpose

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.