| CSV Consultant || Raritan, NJ | Onsite at Raritan, New Jersey, USA |
| Email: [email protected] |
| From: Ambika, Technosphere Inc. [email protected] Reply to: [email protected] Job Description Mandatory Skills CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 Job Description Roles and Responsibilities In addition to validation and regulation experience, the resource should have the following experience. 7 years Experience in the Validating IT software systems like Quality Management System in Life Sciences industry Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation. Experience in validating Global Risk and Compliance modules Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Knowledge of FDA guidances and industry standards Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports) Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process Hands-on experience in software life-cycle management in System data archival process Ability to provide Validation guidance, timely reviews, and escalations to Project teams. Keywords: information technology |
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| Tue Jan 23 22:04:00 UTC 2024 |