Shalin Parikh

Background

About Shalin Parikh

Progressive 8+ years experience in pharmaceutical micro laboratory and Environmental Monitoring. Expert in performing sterility testing in Isolator and VHP decontamination as per USP 71 and SOPs. Expert in performing Microbiological testing on pharmaceutical products (non-sterile, commercial, R&D development, components and stability) as per USP, EP and SOPs. Expert in environmental monitoring (Non-viable particulate count, Active & passive air monitoring, surface monitoring, water testing and cleanroom personal monitoring) in Grade A, B, C&D area. Expert in performing antibiotic-microbial assay (UPS 81), antibiotic/preservative effectiveness testing (PET/AET USP 51), liquid particulate counting testing and BET endotoxin /Pyrogen testing (LAL). Microbial identification of isolates using traditional and rapid methods (Vitek II and API). Expert in microbiological media preparation, sterilizing and growth promotion testing as per USP. Manage, supervise and lead micro lab to ensure all the testing are performed as per GXP and SOPs. Expert in approving, writing and finding root cause for investigation, and implementing CAPA’s using Trackwise. Expert in method/Process validation, method verification and risk Assessment of new product. Competent in adherence to Clean room 100 & 10, (ISO 5 & 7), USP, EP, GXP, OOS and WHIMS. Problem-solver, detail orientated and quick Lerner with strong organizational skills. Extensive knowledge of MS office (Word, Excel and PP), outlook, SAP and LIMS.