Computer System Validation (CSV) Compliance Specialist ...

Position Summary: The Computer System Validation (CSV) Compliance Specialist - Data Integrity will be responsible for executing validation activities for computer systems and software applications, ensuring compliance with regulatory requirements, industry standards, and company policies. This role involves completing periodic reviews for all GMP systems. Key Responsibilities: Execute CSV activities in accordance with regulatory requirements (e.g., FDA, EMA, GxP) and industry standards (e.g., GAMP 5). Prepare and review validation documentation to ensure data accuracy, consistency, and reliability within an organizations database systems and processes. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the life of computerized system remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. Identify and troubleshoot validation issues, providing technical support and recommendations for resolution. Maintain accurate and complete validation records and documentation. Support the CSV Manager in planning and coordinating validation projects to ensure timely completion and adherence to project timelines. Participate in continuous improvement initiatives to enhance the CSV process. Skills and Qualifications: Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field. Minimum of 1 years of experience in computer system validation within the pharmaceutical, biotechnology, medical device, or related industry. Knowledge of regulatory requirements and industry standards related to CSV (e.g., FDA 21 CFR Part 11, GAMP 5, EU Annex 11). Excellent analytical and problem-solving skills, with a keen attention to detail. Effective communication and interpersonal skills, with the ability to collaborate and build relationships with cross-functional teams. Ability to manage multiple tasks simultaneously and meet deadlines. Ability to work independently and as part of a team, with a proactive and results-oriented approach.

Created: 2024-11-16