Position : Validation Lead Location: Round Lake, IL Job Type: Contract
Description: This position is responsible for leading and performing Computer System Validation. The Validation Lead is responsible for monitoring compliance to the GxP and GAMP 5 policies/procedures. 1. Manages the Computer Validation activities and timeline within a project or multiple global projects. 2. Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system as per GxP and GAMP 5. a. Create and review all validation documents in the project. i. Authors Validation Plan, Training Plan, Design Review, IQ Protocol/ Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Trace Matrix, and Validation report. ii. Authors and/or reviews Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description, Standard Operating Procedures and Training records. b. Contributes to or gathers CSV metrics for reporting purposes. 3. Oversight of protocol execution a. Manages the overall protocol execution process, including resource management, scheduling/timeline management, incident management, and status reporting. 4. Participate in the development of CSV training materials. 5. Leads in CSV effectiveness and improvement initiatives. Desired skills / certifications / training 1. Minimum of 6 years experience in Computer Systems or Software Validation including GAMP 5 and GxP procedures. Knowledge of 21 CFR Part 11 and 21 CFR part 820 is a plus. 2. Strong knowledge of project management, QA implementation processes. 3. Validation of Lab instrumentation is plus. Please send your updated Resume to [email protected] -- You received this message because you are subscribed to the Google Groups "Open Source Erp & Crm" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/open-source-erp-crm?hl=en.
