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Microbiologist - job post

St. Stone Medical Devices Privted Limited
Imphal, Manipur
₹30,000 - ₹60,000 a month

Job details

Pay

  • ₹30,000 - ₹60,000 a month

Job type

  • Full-time

Location

Imphal, Manipur

Benefits

Pulled from the full job description

  • Commuter assistance

Full job description

Job Title: Microbiologist Medical Devices

Reports To: QA/QC Manager

Job Summary

Responsible for microbiological testing, environmental monitoring, sterilization validation, and ensuring compliance with applicable standards such as ISO 13485, United States Pharmacopeia, and Indian Pharmacopoeia for medical devices testing.

1. Microbiological Testing

Perform Product bioburden testing, sterility testing, and microbial limit tests.Perform & Maintain sub culturing.Perform Bacterial endotoxin tests.Microbial analysis of purified water systems,

2. Environmental Monitoring(EM)

Monitor cleanroom environments (air, surface, personnel)Perform viable and non-viable particle monitoringTrend analysis of EM data and reporting.

3. Sterilization & Validation

Participate in PQ validation activities of ETO sterilization processes.Biological indicator testing and validation reports.

4. Documentation & Compliance

Prepare SOPs, protocols, and reportsEnsure compliance with:

ISO 13485

ISO 11135

ISO 11737

Medical Device Rules 2017

Support audits (internal, external & regulatory)

5. Training & Support

Train production staff on hygiene and contamination controlSupport QA in batch release decisions.

6.Required Qualifications

B.Sc./M.Sc. in Microbiology / Biotechnolog

7. Key Skills

Knowledge of cleanroom practices and aseptic techniquesFamiliarity with microbiological instruments.Understanding of regulatory standards and validationGood documentation and data analysis skills

Other Perks:-

1. Accommodation

2. Cab Facility for pickup & drop

Pay: ₹30,000.00 - ₹60,000.00 per month

Work Location: In person

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