VALIDATION LEAD (CONTRACT - approx. 12 months)
Our Client is seeking an experienced Validation professional in the San Francisco Bay Area. The Validation Lead will install, validate, and implement ComplianceWire, a SaaS based Learning Management System (LMS) as part of a Part 11/CSV project. The candidate will be responsible for authoring most of the validation documents, and executing many of the documents. We are looking for a candidate who can take control of the project, and manage multiple contributors as well as roll up their sleeves and develop documents. The individual will assure that the client's business process is improved and efficiency increased, while creating a compliant computerized system.
Responsibilities:
• Oversee the installation of the Hardware
• Execute the configuration of the Hardware
• Oversee the software installation & IQ/OQ by the vendor
• Facilitate the business process evaluation and modifications
• Oversee the training and system launch
• Develop and execute the validation package, which includes the following:
• Validation Plan
• Requirements Specifications
• Hardware Qualification Documents
• Hardware Install
• System Configuration Baseline Documents
• System Use SOP
• System Management SOP
• Performance Qualification Protocol
• Performance Qualification Report
• Traceability Matrix
• Summary Report
• Training
• System Release Document
Requirements:
• 8-15 years in the FDA-regulated biotech/pharmaceutical industry, at least 10+ years performing computer system validation.
• Significant experience with 21 CFR Part 11 and Computer System Validation
• Significant project lead experience
• Significant experience generating and executing Validation Life Cycle documents such as Val Plans, URS, IQ/OQ, PQ, & UATP.
• Knowledge of 21 CFR Part 210 & 211
• Proven ability to resolve quality issues/discrepancies with others in a constructive manner is essential.
• Ability to effectively influence and motivate internal and external stakeholders with regard to the validation and implementation of GXP compliant computerized systems.
• Ability to work as a team player in a consulting environment.
• Must be able to work independently with minimal supervision.
• Strong written, communication, and interpersonal skills.