Senior Computer Validation Specialist
Leads the Manufacturing Computerized Support Systems activities related to CSV and Data Integrity Compliance. Responsible for Manufacturing systems validation and maintenance verification including sterile systems and equipment. The position must comply with Security, Environmental Health and Safety, and cGMP policies and regulations required by the job function. Performs evaluation of the validation and Data Integrity requirements of the Sterile Manufacturing Computerized System and ensure maintenance activities are performed to assure an efficient workflow during the usage of the related systems. Prepares and reviews the Computerized Support Systems documentations and provides comprehensive training to manufacturing personnel on Manufacturing Computerized System. Defines and develops user requirements specification and/ or function requirements for Computerized Systems as applicable to assure new systems are in compliance with data integrity requirements. Ensures automated systems are maintain in state of compliance with local and corporative policies and procedures, including data integrity requirements. Evaluates, recommends and implements new automation, computerized systems and administrative tools to improve data integrity compliance and the efficiency of manufacturing operations.
Requirements: Bachelor Degree in Engineering, Information Technology Systems, Science or related field. At least ten (10) years of experience in the pharmaceutical industry, specifically CSV and IT Compliance.
• Experience and knowledge in computerized systems validation and life cycle requirements
• Experience with Sterile Manufacturing systems and equipment
• Experience using computerized systems as continuous improvement tool associated with manufacturing performance optimization
• Computer literate, able to read interpret and technical literature regarding computerized systems applying concepts to strategically solve execution issues
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience computerized system validations methodologies, 21 CFR Part 11, and Data Integrity regulations
• Experience performing equipment troubleshooting
• Excellent Good communication skills (oral and written) in Spanish and English
• Willing to work irregular hours, weekends and holidays as required.
With Kelly, you'll have direct connections to leading IT organizations in the best companies around the globe—offering you the chance to work on some of today's most intriguing, innovative and high- visibility projects. In a field where change is the only constant, our connections and opportunities will help you take your career exactly where you want to go. We work with 95 of the Fortune 100™ companies, and more than 3,000 IT hiring managers turn to us each year to access the best talent: people like you.
Last year we found 8,000 opportunities for IT professionals. Let us help advance your career today.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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