CSV Consultant - System Validation

Location : Remote Experience : 5 Years in Computer System Validation (CSV) and GxP regulated environments About the Role : We are seeking experienced and highly motivated freelance CSV & GxP Consultants to join our team. As a key member, you will provide expert guidance and support in managing and validating IT systems within a GxP regulated environment. You will be responsible for ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry best practices. This role demands a strong understanding of IT infrastructure, change management, and incident/problem resolution, coupled with meticulous documentation and validation skills. Responsibilities : - Provide day-to-day management and support of GxP regulated IT systems. - Ensure systems operate in a compliant and efficient manner. - Maintain system integrity and data security. - Develop, execute, and review validation documentation (e.g., Validation Plans, User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Test Protocols, Validation Summary Reports). - Perform risk assessments and ensure appropriate validation strategies are implemented. - Maintain a thorough understanding of current regulatory requirements and industry best practices related to CSV. - Provide expertise in IT infrastructure components relevant to GxP systems. - Ensure infrastructure compliance with regulatory requirements. - Work with infrastructure teams to maintain systems. - Manage changes to GxP systems through a controlled change management process. - Ensure all changes are properly documented and validated. - Oversee the release management process to ensure smooth and compliant system updates. - Respond to and resolve incidents and problems related to GxP systems. - Conduct root cause analysis and implement corrective and preventive actions (CAPA). - Maintain accurate records of incidents and problem resolutions. - Create and maintain comprehensive documentation, including SOPs, work instructions, and validation reports. - Ensure all documentation is accurate, complete, and compliant with regulatory requirements. Compliance : - Ensure all work complies with applicable GxP regulations and internal policies. Mandatory Skills : - Minimum 5 years of experience in CSV within a GxP regulated environment (e.g., pharmaceutical, biotechnology, medical device). - Strong working knowledge of Computer System Validation principles and practices. - Extensive experience in GxP system management. - Proven experience with IT infrastructure management. - Demonstrated expertise in change and release management processes. - Proficiency in incident and problem management. - Excellent documentation and communication skills. - Understanding of 21 CFR Part 11 and EU Annex 11. Preferred Skills : - Experience with specific GxP systems (e.g., LIMS, ERP, QMS). - Knowledge of ITIL framework. - Experience working with cloud based GxP systems. - Experience with automated testing tools. Personal Attributes : - Highly organized and detail-oriented. - Strong analytical and problem-solving skills. - Ability to work independently and as part of a team. - - Excellent communication and interpersonal skills. - Ability to manage multiple projects and priorities. - - Self motivated. (ref:hirist.tech)

Location: in, IN

Posted Date: 5/12/2025