Katalyst Healthcares & Life Sciences
Validation Analyst, Laboratory
Katalyst Healthcares & Life Sciences, South Plainfield, New Jersey, us, 07080
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr