Provide advice, interpretation, help and training to other departments, in GCP, SOPs, regulatory issues and internal company policies related to Quality Assurance. Lead and manage the QA aspects of IT system validation activities, including document review, filing, system uploads, and approvals, ensuring compliance with relevant regulations (e.g., GCP). Maintain QA databases and electronic file systems related to IT system validation, change control, and audit trails. Oversee and maintain the IT system inventory list, ensuring accuracy and completeness of all documented systems. Independently manage the IT system change control process, including review, assessment, and approval of changes to validated systems. Provide expert advice, interpretation, and training on CSV requirements, GAMP 5 principles, and relevant regulatory guidelines Create, update and collect SOPs, templates and forms/documents. Participate in and contribute to the review and follow-up of corrective and preventive action plans (CAPAs) arising from IT system audits, deviations, and regulatory inspections. Support the Quality Assurance team in the coordination of internal and external audits, including readiness activities specific to IT systems and CSV. Assist in audit preparing activities such as Quality Assurance Administrative Tasks (Agenda, audit plan), readiness of the QMS data, data collection, follow up activities and assisting other departments Track and ensure compliance with timelines for IT-related quality activities, including system reviews, approvals, and training Support cross-functional teams (e.g., IT, Data Management) in ensuring the quality and compliance of computerized systems throughout their lifecycle. Manage the end-to-end process for training within the Learning Management System (LMS), including creation, assignment, and disabling of training. Contribute to the development and monitoring of Quality Key Performance Indicators (KPIs) related to IT system compliance and identify areas for improvement. Follow up on compliance with the times and manner of the employees in terms of revision, signature or training on issues of Quality Assurance. Assist the Quality Assurance Department with completing all required tasks to meet departmental and project goals e.g.: planned audit reports, Controlled Documents targets, preparation of quality metrics and annual reports; overdue response, training compliance, scheduling/maintaining calendar, email correspondence, etc. Any other reasonable task that derives from the previous ones or the position requires.
Role & responsibilities: Promote and adhere to the values of the organization, Integrity, Innovative to Differentiate, Dependable and Trusted Partner, Quality on Time and Grow Collectively Manage or lead multiple project assignments and programming team by acting as point of contact with the Project Management and sponsor team to ensure smooth coordination of the projects Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Company Standard procedures and policies Develop and/or validate specification, programming for CDISC Data Standards, TFL programming for complex studies Develop and manage metrics on a periodic basis to enable sufficient and consistent feedback and identify improvement areas and create a training plan as required Identify changes to the approved project plan and manage through a change control process which reviews impact on timelines, budget and resources Provide inputs on baseline estimations, new business proposals and project plans as required Produce accurate resourcing plans in conjunction with assigned Project Team Members Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed) Timely completion of client specific and organization specific training documentation Workload forecast for the team and provide a vision of the ongoing project objectives or milestones and provide clarity on the upcoming projects Assist in the development and maintenance of the SAS programs/macros, templates and utilities for data cleaning and reporting and to perform Reconciliation of the External data Provide mentorship for associates working on the project and support training requirements for the trainees or team members Involve in process improvement activities to improve the current processes and achieve efficiency and enable the processes are in line with the Regulatory/Industry requirements Setting up challenging, achievable goals for associates which contribute to department objectives and support efforts to achieve those goals Provide timely performance feedback to associates on a routine basis as well as during Annual performance review Supervision on project status, budget expenditures on regular basis, identify any problem and recommend solution.