Executive

Key Responsibilities:

• Environmental Monitoring:

• Perform routine environmental monitoring of cleanrooms and controlled manufacturing areas.
  
• Monitor viable and non-viable particulates in aseptic and non-aseptic areas.
  
• Collect surface, personnel, and air samples following standard protocols.
  

• Water Sampling & Testing:

• Conduct regular sampling and microbiological testing of purified water (PW), water for injection (WFI), and other utility systems.
  
• Analyze total microbial count and alert/action limits as per pharmacopeial and regulatory guidelines.
  

• Microbial Testing:

• Perform microbial limit tests on raw materials, finished products, and in-process samples.
  
• Identify and document any out-of-specification (OOS) or out-of-trend (OOT) results, initiate investigations, and support CAPA processes.
  
• Maintain test logs and laboratory notebooks accurately and in compliance with data integrity standards.
  

• Media Preparation:

• Prepare and qualify culture media and reagents as per SOPs and quality requirements.
  
• Ensure proper storage, labeling, and sterility of prepared media.
  
• Maintain media inventory and monitor expiry dates.
  

• Compliance and Documentation:

• Adhere to current Good Manufacturing Practices (cGMP) and relevant pharmacopeial guidelines (USP, EP, JP).
  
• Maintain and review laboratory documentation including SOPs, logbooks, test records, and equipment usage logs.
  
• Participate in internal and external audits, providing necessary documentation and support.