Full-Time IT Validation Coordinator

• Develop and implement IT validation strategies and plans for computer systems and equipment used in pharmaceutical processes
• Coordinate validation activities with cross-functional teams, including IT, Quality Assurance, and Manufacturing
• Create and review validation documentation, including validation plans, protocols, and reports
• Ensure compliance with FDA, EMA, and other relevant regulatory requirements
• Conduct risk assessments and gap analyses for IT systems and processes
• Manage validation projects, timelines, and resources efficiently
• Collaborate with vendors and internal stakeholders to resolve validation-related issues
• Stay up-to-date with industry trends and regulatory changes in IT validation and pharmaceutical compliance
• Provide training and guidance to team members on validation procedures and best practices
• Participate in audits and inspections related to IT systems and validation processes

• Bachelor's degree in Computer Science, Information Technology, or a related field
• 3-5 years of experience in IT validation within the pharmaceutical industry
• Strong knowledge of IT validation methodologies and practices
• Proficiency in computer systems validation (CSV) and related documentation
• Familiarity with pharmaceutical industry regulations, including FDA and EMA guidelines
• Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• Excellent project management skills with the ability to manage multiple projects simultaneously
• Strong analytical and problem-solving skills
• Proficiency in Microsoft Office Suite and validation documentation tools
• Excellent written and verbal communication skills
• Ability to work effectively in a team environment and collaborate with cross-functional groups
• Detail-oriented with a strong focus on accuracy and quality
• Certifications in IT validation or pharmaceutical quality assurance (preferred)
• Experience coordinating validation activities for software systems and equipment in a pharmaceutical setting
• Knowledge of IT systems used in pharmaceutical manufacturing and research

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