Executive

Please note:

Only For Male Candidates due to shift support

The candidate will be responsible for performing microbiological analysis and ensuring compliance with cGMP, regulatory, and company quality standards in an API manufacturing environment.

Key Responsibilities

• Perform

  microbiological testing

  of:
• Raw materials
  
• Finished API products
  
• In-process samples
  
• Water samples (PW, DM, WFI if applicable)
  
• Conduct

  environmental monitoring

  :
• Cleanroom monitoring (air, surface, personnel)
  
• Viable and non-viable particle monitoring
  
• Perform

  sterility testing

  ,

  bioburden

  ,

  endotoxin (LAL)

  testing as applicable
• Handle

  media preparation

  , media growth promotion tests, and media qualification
• Perform

  microbial limit tests (MLT)

  as per pharmacopeial requirements
• Maintain and update

  SOPs

  , test records, logbooks, and documentation
• Ensure compliance with

  cGMP, GLP, GDP

  , and

  Data Integrity

  requirements
• Participate in:
  
• Investigations (OOS, OOT, deviations)
  
• Root cause analysis and CAPA implementation
  
• Support

  internal audits

  ,

  regulatory inspections

  (USFDA, WHO, EU, etc.)
• Monitor and trend microbiological data
  
• Handle qualification and calibration support for microbiology lab instruments
  
• Coordinate with production, QA, and engineering teams when required