Senior Executive - QC Microbiology

Roles and Responsibilities

• Oversee & conduct environmental monitoring, water sampling, BET, MLT, Sterility testing, and LIMS activities as per SOPs.
• Oversee & ensure microbiological analysis of samples using various techniques such as BET, MLT, Sterile technique.
• Participate in external and/or regulatory inspections of Microbiology operations at the site.
• Participate in the investigation of out-of-Specification results, out of trends results, conduct investigation for root cause analysis/corrective actions and systems to ensure compliance to quality requirement. Handling of Change control and CAPA management.
• Ensure consistency in Microbiology lab operations and drive continuous improvements in laboratory performance.
• Ensure compliance to cGMP/GLP and applicable safety standards in the Microbiology laboratory.
• Review logbooks, Instrument calibration records, Instrument Periodic performance records, data summary reports and certificate of analysis for accuracy and completeness.
• Review logbooks, Instrument calibration records, Instrument Periodic performance records, data summary reports and certificate of analysis for accuracy and completeness.
• Participate in audits conducted by regulatory agencies such as USFDA.
  

Desired Candidate Profile

• 12-15 years of experience in Microbiology department.
• Must have worked in Ophthalmic or Sterile Injectable formulations.
• Must have faced USFDA audit

📝 Interested candidates can share their resume at 📧parichayindore@lupin.com.

🔗 Register in below link
https://lnkd.in/dxQapSFy