GxP Validation Lead
4 weeks ago
Role: GxP Validation Lead
Location: Onsite at Alameda, CA (2-3 Days)
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.
In this role you will
- 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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