Department : Field - FG Location : Juncos, 077
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :
- Specialist QA
- Shift : Mon / Tue then Fri / Sat / Sun on alternate weeks from 5 : 00 AM to 5 : 30 PM or from 5 : 00 PM to 5 : 30 AM.
Summary
Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx / MES application, MAXIMO, SAP and LIMS.
Functions
Review and approve product MPs.Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team.Approve Environmental Characterization reports.Release of sanitary utility systems.Approve planned incidents.Represent QA on NPI team.Lead investigations.Lead site audits.Own site quality program procedures.Designee for QA manager on local CCRB.Review Risk Assessments.Support Automation activities.Support facilities and environmental programs.Review and approve Work Orders.Review and approve EMS / BMS alarms.Approve NC investigations and CAPA records.Approve change controls.Provide lot disposition and authorize lots for shipment.EDUCATION / LICENSES
Doctorate degree, or Master's degree and 3 years, or Bachelor's degree and 5 years of directly related experience.START YOUR APPLICATION