- 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
- 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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Product Validation Lead
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Validation Lead
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Katalyst Healthcares and Life Sciences Oakland, United StatesResponsibilities : ct as a Validation Lead for multiple products (applications) for GxP compliance · ssist 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 valid ...
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Product Validation Lead
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Facebook Sunnyvale, United StatesThe Product Validation Team is a key team in the Wearable Product Organization that focuses on end-to-end systems validation from new product introduction, new technology introduction, factory readiness, product launch and post-launch testing. As a Product Validation Lead, you wi ...
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Power Validation Lead Engineer
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Power Validation Lead Engineer
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Quest Global Sunnyvale, United StatesRequired Skills (Technical Competency): · 8+ years of experience in Power consumption measurement of various device use cases done in on-site lab environment. · Debugging power regressions by analyzing electrical results and device logs. · Ability to network, build relationships ...
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Computer Systems Validation Lead
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Validation Lead - Alameda, United States - I.T. Solutions, Inc.
Description
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.
Skills and Qualifications
