Approved Microbiologist - Deputy Manager Microbiology ( Injectable )

Role & responsibilities

• Perform and approve

  Sterility Testing

  using direct inoculation or membrane filtration methods as per pharmacopeial standards (USP, EP, IP, JP).
• Supervise aseptic testing procedures in ISO Class 5 (Grade A) environments within

  validated sterility testing isolators or LAFs

  .
• Ensure

  environmental monitoring

  ,

  personnel monitoring

  , and

  media fill (ASEPTIC Process Simulation)

  activities are conducted and reviewed as per schedule.
• Approve microbiological testing results, including

  bioburden

  ,

  endotoxin

  ,

  water testing

  , and

  identification of microorganisms

  .
• Conduct

  investigations

  of microbiological OOS/OOT results and

  deviations

  , and support implementation of corrective and preventive actions (CAPA).
• Maintain and review

  sterility testing records

  , SOPs, protocols, and reports for accuracy and regulatory compliance.
• Participate in

  regulatory inspections

  and internal audits.
• Provide

  training

  to QC microbiology staff on aseptic techniques, gowning, sterility testing, and contamination control.
• Ensure microbiological methods are

  validated

  and kept up to date per pharmacopeial updates.
• Maintain inventory and calibration status of microbiology lab equipment used in sterility testing.
  
• Review and approve environmental monitoring data related to aseptic processing areas.
  

Preferred candidate profile

• Attention to detail and high level of documentation accuracy.
  
• Strong aseptic technique and contamination control awareness.
  
• Analytical thinking and sound decision-making in compliance-driven environments.
  
• Ability to work independently and in a team.
  
• Good communication skills (written and verbal).