Microbiologist - Pharmaceutical QC

Aviiral Medicare; Indore District; On-site; INR 550,000 - 900,000; Full time

Job summary

Aviiral Medicare seeks a Microbiologist to establish and operate the microbiology laboratory and monitoring program for a non-sterile pharmaceutical facility in Indore. The role includes developing SOPs, test methods, sampling plans and records, and ensuring rigorous environmental monitoring.

The ideal candidate has 5+ years in pharmaceutical microbiology, holds an M.Sc. in Microbiology, and can lead documentation, investigations and audits. Experience setting up a new lab is advantageous.

Qualifications

• 5+ years in pharmaceutical microbiology preferred.
• Applicants should have practical experience in non-sterile pharmaceutical microbiology, including water testing and environmental monitoring.
• Experience setting up a new microbiology laboratory is an advantage.

Responsibilities

• Prepare microbiology SOPs, specifications, test methods, sampling plans, worksheets and records.
• Perform microbial enumeration, tests for specified microorganisms and method suitability work, as applicable to raw materials, water and finished products.
• Plan and perform purified-water sampling and microbiological testing; maintain point-wise records and review trends.
• Establish environmental monitoring procedures, sampling locations, frequencies, alert/action limits and trend reports in coordination with QA.
• Manage media preparation, sterilization, growth-promotion testing, media inventories and related records.
• Maintain reference cultures, culture handling records, equipment logbooks and calibration or qualification schedules.
• Support qualification of microbiology equipment and areas, and document the associated studies.
• Review raw data, identify atypical results and investigate excursions or OOS findings with QC and QA.
• Train laboratory staff in microbiology methods, aseptic technique, contamination control and documentation.
• Present microbiology systems and records during inspections and customer audits.

Skills

Environmental monitoring

Water testing

Documentation

CAPA investigations

Education

M.Sc. Microbiology

Job description

Experience: 5+ years in pharmaceutical microbiology preferred

Qualification: M.Sc. Microbiology or a relevant postgraduate qualification

Role overview

We are seeking a Microbiologist to help establish and operate the microbiology laboratory and monitoring programmed for a non-sterile pharmaceutical facility.

Key responsibilities

• Prepare microbiology SOPs, specifications, test methods, sampling plans, worksheets and records.
• Perform microbial enumeration, tests for specified microorganisms and method suitability work, as applicable to raw materials, water and finished products.
• Plan and perform purified-water sampling and microbiological testing; maintain point-wise records and review trends.
• Establish environmental monitoring procedures, sampling locations, frequencies, alert/action limits and trend reports in coordination with QA.
• Manage media preparation, sterilization, growth-promotion testing, media inventories and related records.
• Maintain reference cultures, culture handling records, equipment logbooks and calibration or qualification schedules.
• Support qualification of microbiology equipment and areas, and document the associated studies.
• Review raw data, identify atypical results and investigate excursions or OOS findings with QC and QA.
• Train laboratory staff in microbiology methods, aseptic technique, contamination control and documentation.
• Present microbiology systems and records during inspections and customer audits.

Candidate profile

Applicants should have practical experience in non-sterile pharmaceutical microbiology, including water testing and environmental monitoring. Strong documentation, investigation and data-review skills are essential. Experience setting up a new microbiology laboratory is an advantage.