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Responsibilities:

• Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
• Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
• Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
• Performs related duties as assigned.

Requirement:

• Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience
• 21CFR11/ EU GMP Annex 11 and GAMP 5 standards
• Data Integrity Guidance
• Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
• Project management practices and techniques
• Software development life cycle
• Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
• Principles and practices of computer compliance, validation and qualification
• Knowledge of automated testing practices and tools a plus
• External and internal inspections
• Stakeholder management in a cross-functional organization
• Reviewing user, functional and design specifications.
• Reviewing and executing protocols and test scripts
• Sampling, testing and measuring techniques.
• Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
• Selecting, training, supervising and evaluating departmental personnel
• Managing multiple projects, duties and tasks,
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining effective working relationships with those contacted in the course of work.