Senior Consultant
Current• Working in system validation, change management and Quality Assurance by defining SOPs, User manual, Test protocol, Traceability Matrix, Summary Report and Compliance analysis, pre/post approving change requests• Accountable for creating Validation plan, defining validation strategy, OQ, PQ and Risk analysis• Performing GAP analysis, root cause analysis on process deviation• Involved in preparation and review of test summary report also preparing Individual case safety reports into the safety database (Pharmacovigilance)• Proactively contributing to evolvement and implementation of configuration of ARISg products for specific clients with best practices and improvements• Ensuring compliance to Applicable Global Requirements, Good Pharmacovigilance Practices and Applicable SOPs in relation to of ICSR Processing• In-depth understanding of the regulatory guidelines for IT systems– primarily FDA, EMA, MHRA and PMDA
