Job Description :
Need 6 - 8 years resume
Job Description:-
Review, assist, and in some cases prepare computer system validation deliverables (documentation, testing, and change controls) for MTI computer systems in accordance with relevant regulatory protocols such as 21CFR parts 11, 210, and 211. Review implementation deliverables to ensure items will meet regulatory and Client's Standard Operating Procedure requirements. Collaborate and learn new Automation and Computer Systems in order to serve as a CSV liaison for systems.
Participate in gathering the appropriate level of information needed to complete validation documentation. This will require communicating with the proper business, IT and QA personnel to gain the necessary information as well as acquiring proper review and approval activities. This will also require attending and coordinating meetings to complete validation documentation.
Provide validation guidance to implementation teams on an ongoing basis. Create and champion standards for validation process and deliverables. Create and maintain documentation templates to speed the documentation process.
Assist in maintaining schedules for assigned project tasks and coordinating validation tasks (documentation, testing, training, and change controls) with the project manager and team members. Perform follow up on deliverable related tasks with assigned parties. Ability to plan and schedule validation projects. Respond to team members requests for assistance in creating content for validation (documentation, testing, and change controls As part of project delivery, drive validation workstreams and identify solutions.
Provide management of validation master files, testing project(s), and Trackwise/CMDB CI''s including maintaining appropriate controls, quality standards and consistency as required by management. Prepare for planned regulatory authority audits. Respond to requests for access and questions on validation deliverables. Respond to quality audits from internal and external audit constituencies.
Perform Computer System Validation functions to meet the goals and objectives of a project. Responsible for development and execution of validation function deliverables to support one (or many) projects to include technical development, validation testing, change management / controls, and documentation (SOP''s, validation plans, design specs, protocols, architecture specs, and reports) and training.
Provide project oversight for validation processes and procedures; and implements changes and/or improvements to meet appropriate regulatory requirements, internal policies and current industry practices. Actively represent Computer System Validation on Project teams globally with respect to the interpretation and application of regulatory requirements concerning validation.
Provide support to the IT and QA organizations and project teams to ensure harmonized and consistent use of CSV standards, templates and procedures for computer system validation for Enterprise Systems with focus on GMP / regulated systems and technologies.
Identify opportunities for continuous improvement of validation philosophy, practice, and procedure to ensure the highest standards.
Support Initial Risk Assessment and/or functional risk assessment discussions pertaining to CSV.
Identify and provide updates for IT CSV Policy and SOPs for Document Management, Change Management, and Testing activity.
Assist project teams with CMDB strategy for application set up in client's ITIL tool