Microbiology Officer

Sun Pharma; Kamrup Metropolitan, Kamrup; On-site; INR 600,000 - 900,000; Full time

Job summary

Sun Pharma is seeking professionals for microbiological testing, environmental monitoring, sterility assurance, and CAPA management within a GMP-compliant environment in India. You will handle analysis across materials, water systems, finished products, and samples, while contributing to investigations and regulatory readiness.

The role includes documentation, training coordination, and cross-functional collaboration with QA, Engineering, and Validation teams to ensure product quality and

Responsibilities

• Perform microbiological analysis of Raw Materials, Water Systems (Purified Water, WFI), Finished Products, In-process Samples, Compressed Gases and Environmental Monitoring Samples.
• Conduct sterility testing, microbial limit testing, bioburden testing, endotoxin testing, and growth promotion testing.
• Review and evaluate microbiological test results for compliance with specifications.
• Execute environmental monitoring of classified manufacturing areas including Viable Air Monitoring, Non-Viable Particle Monitoring, Surface Monitoring, and Personnel Monitoring.
• Trend environmental monitoring data and identify adverse trends.
• Support investigations of environmental excursions and microbiological deviations.
• Participate in contamination control strategies within sterile manufacturing operations; perform media fill studies and aseptic process simulations.
• Monitor cleanroom microbiological status and recommend corrective actions; ensure aseptic practices and cleanroom procedures.
• Maintain accurate laboratory records, logbooks, worksheets, and reports; support GDP and Data Integrity requirements.
• Participate in internal audits, customer audits, and regulatory inspections; prepare and present microbiological data during audits.
• Provide GMP and microbiological awareness training to manufacturing personnel; coordinate with Production, QA, Engineering, Validation, and Warehouse teams.

Skills

Microbiological analysis

Environmental monitoring

Sterility support

Laboratory operations

CAPA investigations

Documentation practices

Regulatory compliance

Training coordination

Tools

Incubators

Autoclaves

Biosafety Cabinets

Particle Counters

Endotoxin Testing Systems

Colony Counters

Job description

Microbiological Testing

• Perform microbiological analysis of:
  • Raw Materials
  • Water Systems (Purified Water, WFI)
  • Finished Products
  • In-process Samples
  • Compressed Gases
  • Environmental Monitoring Samples
• Conduct sterility testing, microbial limit testing, bioburden testing, endotoxin testing, and growth promotion testing.
• Review and evaluate microbiological test results for compliance with specifications.

Environmental Monitoring (EM)

• Execute environmental monitoring of classified manufacturing areas including:
  • Viable Air Monitoring
  • Non-Viable Particle Monitoring
  • Surface Monitoring
  • Personnel Monitoring
• Trend environmental monitoring data and identify adverse trends.
• Support investigations of environmental excursions and microbiological deviations.

Sterility Assurance & Contamination Control

• Support contamination control strategies within sterile manufacturing operations.
• Participate in media fill studies and aseptic process simulations.
• Monitor cleanroom microbiological status and recommend corrective actions when required.
• Ensure compliance with aseptic practices and cleanroom procedures.

Laboratory Operations

• Prepare and manage microbiological media, reagents, cultures, and controls.
• Operate and maintain laboratory equipment such as:
  • Incubators
  • Autoclaves
  • Biosafety Cabinets
  • Particle Counters
  • Endotoxin Testing Systems
  • Colony Counters
• Ensure laboratory housekeeping and 5S compliance.

Investigation & CAPA Management

• Participate in investigations related to:
  • OOS (Out of Specification)
  • OOT (Out of Trend)
  • Environmental Monitoring Excursions
  • Sterility Failures
  • Microbiological Deviations
• Perform root cause analysis and support implementation of CAPA.
• Monitor effectiveness of corrective and preventive actions.

Documentation & Compliance

• Maintain accurate laboratory records, logbooks, worksheets, and reports.
• Ensure compliance with Good Documentation Practices (GDP) and Data Integrity requirements.
• Prepare and review SOPs, protocols, reports, trends, and microbiological risk assessments.
• Support qualification and validation documentation.

Audit & Regulatory Support

• Participate in internal audits, customer audits, and regulatory inspections.
• Prepare and present microbiological data during audits.
• Ensure inspection readiness of microbiology laboratory and manufacturing areas.
• Support compliance with USFDA, MHRA, EU GMP, WHO-GMP, and PIC/S requirements.

Training & Cross-Functional Coordination

• Provide GMP and microbiological awareness training to manufacturing personnel.
• Coordinate with Production, Quality Assurance, Engineering, Validation, and Warehouse teams.
• Support continuous improvement initiatives related to contamination control and sterility assurance.