The individual in this position implements policies and procedures to validate/qualify computer systems. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
• Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Lead process improvement projects to improve the validation of computerized systems
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
• Trains /advises less experienced Specialists and Technicians.
• Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
• Technical writing experience.
• Generation of Validation documents.
• Review and Approval of Validation documents.
• Strong attention to detail and accuracy.
• Experience in risk assessments in relation to validation activities.
• Advise and support all teams on computer validation activities.
• Requires BS/BA in Engineering, Chemistry, or Life Sciences.
• 3+ years of related experience within the fields of computers and biotechnology.
• Will substitute relevant experience for education. Experience with process control systems necessary.
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