Validation Lead

2 weeks ago

New York, United States IT Solutions LLC Full time

Role: GxP Validation Lead Location: Onsite at Alameda, CA (2-3 Days) Duration: Long Term Rolling Contract

The Validation Lead will be the primary liaison between product and quality teams to help validate number of products. The role will leverage strategic mindset to transform and adopt a risk-based approach to move the client towards Software Assurance. Act as a Validation Lead for multiple products (applications) for GxP compliance Assist building a standardized method of enabling / implementing the SOPs for the GxP applications and getting the teams to adopt the standard approach Manage and execute validation plans and validation documents for new systems in scope Analyze and propose changes to already validated systems and recommend requisite level of validation activities Act as project manager for validation projects process Responsible for overseeing other teams / individuals that are doing the actual executions (lead/coordinate/manage) Act as single point of contact to plan, gauge workload, and help the multiple teams streamline to standards for multiple teams responsible for the validation of their individual products Coordinate with business to support the required software change Help create system requirements and specifications to ensure requirements can be tested to meet the validation goals Support auditing of internal computer systems validation activities, protocol and procedures along with preparing appropriate responses Initiate / Prepare and closeout all validation related deviations, discrepancies and change control documents Support development teams in creating, and maintaining test plans, test scripts and user acceptance tests Manage the execution of test plans Guide the teams in the proper execution of validation documents

Skills and Qualifications Overall 15+ years IT experience 8+ years of relevant experience in computer system Validation preferably in a pharma company Experience and good knowledge in CSV / CSA Experience in managing other teams and individuals Knowledge of GxP Have good organization skills Ability to work on multiple projects in parallel Good verbal and written communication skills Ability to provide guidance on revising validation documents and protocols

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