QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities:
Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulationsCoordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, globalIdentifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applicationsReports on the status of validation activities to fulfill regulatory requirementsPerforms system administration and configuration of quality information technology systemsPerforms investigation non-conformance eventsInitiates, recommends, and provides solutions to the Non-Conforming Product as per proceduresVerifies the implementation and effectiveness of non-conforming CAPAExecutes job responsibilities as established in the proceduresFollows the documentation procedures Non- Conformance ResolutionEvaluating, Investigating & Completion of Non- ConformanceInvestigation ( Data gathering of Quality issue)Identify Corrective/Preventive ActionsImplementing Corrective/Preventive ActionsLead complaint activities with the Operating Units membersQualifications:
Bachelor in Engineering2+ years of relevant experienceKnowledge of Good Manufacturing PracticesLean Six Sigma Green Belt CertificationMicrosoft Office (Excel, Word, Outlook, Power Point, Project), Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line ToolGood oral and written communication skills (English and Spanish)Availability to work overtime and weekends when necessaryGood problem-solving skillsAvailability for 1st shift
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