Jessica P.'s Contact Details

Jessica P.'s Company Details

Pharma Bio Expert

LAVAL, QUEBEC, CA • 20 - 49 Employees
Warehousing/Logistics

Pharmaceuticals | Biotech | Nutraceuticals | Cosmetics | Hospitals & Pharmacies Clean Rooms | Medical Devices | FoodsIndependent Compliance Review & Audit (cGMP, ISO14644, ASME-BPE, HSE):o Sanitary process design & engineering (PFD, P&ID, layout & technical specifications)o Classified cleanrooms functional analysis of (A, B, C, D, ISO5-8)o Physical & mechanical segregation requirementso Cross flow & contamination risk analysiso Aseptic design analysis of cleanrooms, equipment, & products o Biological containment facilities design (BSL2, 3, 4)o High potent facilities design (HP1-5, OEL: 1@+1000 µg/m3)o Risk analysis assessment, & mitigation (FMEA, ATEX)o Risk management tools for prevention, disinfection, biodecontamination, sanitation, and maintaining levels of protection.Construction & project management (EPCMV)o Supervision of delivery, Installation, Commissioning (FAT, SAT) & start-upo On site construction & installation works follow-up & Benchmarko Approval of validation protocols and reports of DQ, IQ, OQo Management of predictive, preventive& routine maintenanceo Management of calibration, sampling & change control programso cGMP training.cGMP Engineering Compliance & Project ManagerC. 1.514-616-2692 | www.pharmabioeng.comhttp://www.pharmabioeng.com/index.php?page=homehttp://www.pharmabioeng.com/index.php?page=compliancehttp://www.pharmabioeng.com/index.php?page=project-managementPBE, Your c-GMP Regulation & Engineering Compliance & PM Partner