Computerized System Validation Specialist

59230 - Computerized System Validation Specialist - TAPI

How you’ll spend your day:

• Responsibility for Global and Local Computerized system (Computerized system technical owner), adequacy, maintenance and validation activities. Compliance to CFR Part 11, annex 11.
• Provide quality support and guidance to operation, qualification, validation, monitoring and maintenance of Critical Systems as Purified water, HVAC systems, Process gases as Nitrogen, air etc.
• Environmental monitoring
• Data Integrity
• SOP's
• External and Internal audits
• API shipments monitoring
• Employees qualification and Training
• Handle supplier quality management, including supplier qualification and evaluation, Quality agreements and conducting supplier quality audit

Your experience and qualifications:

• BSc. in life science/ engineering or similar field
• Experience in Computerized System and validation of computerized system following CFR Part 11 and Annex 11.