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Validation Analyst, Laboratory

Company: Jobleads
Location: Plainfield
Posted on: June 4, 2021

Job Description:

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: Strong knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211. Working experience in a regulated Pharmaceutical industry in the areas of Research/Lab areas. Strong expertise on lab system validation process including instrument commissioning/decommissioning, calibration, new lab set up, etc. Requirements: Having experience writing Validation work products: Master Plans, Risk Assessments, Installation Qualification Protocols, Operational Qualification Protocols, Performance Qualification protocols. Experience in performing risk analysis and risk-based validation including GAMP5. Knowledge of CAPA, handling deviations, Investigations. Excellent Communication Skills and relationship building with end user scientific community Experience around SDLC documentation applicable to lab/instruments Ability to work independently with minimal supervision. Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Jobleads, Plainfield , Validation Analyst, Laboratory, Other , Plainfield, New Jersey

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