Validation Specialist

Validation / Qualification Specialist : Performing tasks related to the validation and qualification of the processes, procedures, equipment, facilities, and utilities that are used in the manufacture of pharmaceutical products on a commercial scale. RESPONSIBILITIES : Implement the validation and qualification policies, procedures, and annual plans.Execute the validation and qualification program/activities and create the related validation document.Assist in the preparation and updating of Validation and qualification Master Plans. Assist in the preparation of validation and qualification protocols and reports. Execute the validation cleaning program. Execute the computerized system validation plan. Execute the temperature mapping activities for all PSI warehouses and trucks.Assist in the review of all qualification documents (URS, DS, DQ, IQ, OQ and PQ).Execute revalidation plan for the facilities, utilities, equipment’s, processes etc.Assist in the performance of quality risk assessments in the following areas: Process Validation, Cleaning Validation, Equipment Qualification, Product validation, area qualification, and any other activities related to validation/qualification.Provide assistance and guidance in training of co-workers during the execution of validation protocols and operating procedures.Ensure proper archiving and retrieval of validation documents.To participate in different technical work teams (i.e. investigations, committees, audits, FATs, etc.) as needed. Education:Bachelor’s degree in science, Engineering or PharmacyExperience:1 -3 years of Validation/ Qualification experience in the pharmaceutical industry.Job related Skills:Planning and organizing.Critical Thinking &Problem solving.Communication (verbal & written).Self-Management.Computer Literacy (MS Project).