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
- 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.
- 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.
- Water System Monitoring Perform microbiological testing of purified water and process water. Monitor water quality trends. Investigate out-of-specification results. Recommend corrective actions.
- 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.
- 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.
Prepare CAPA reports. Verify effectiveness of corrective actions.
- Validation Activities Support cleaning validation. Support sterilization validation. Support process validation activities. Participate in risk assessments.
- 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.