8 - 12 years
7 - 10 Lacs
Posted:5 days ago|
Platform:
Work from Office
Full Time
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).
Venus Remedies (VRL)
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