Controller

Role Overview: As a Change Controller at NovintiX, you will play a crucial role in supporting the development, implementation, and maintenance of global change control processes to ensure regulatory compliance, operational efficiency, and audit readiness. Your responsibilities will involve cross-functional coordination, documentation accuracy, and timely execution of change control activities using platforms like COMET and Windchill. Key Responsibilities: - Create and manage change control records in COMET/Windchill based on SME inputs. - Ensure clarity in describing change scope, impacted functions/sites, risks, and stakeholder involvement. - Prepare and maintain change control plans aligned with regulatory and operational standards. - Organize and facilitate pre-change alignment meetings. - Prepare slide decks and summaries for Change Control Board (CCB) endorsement. - Identify assessors and approvers and ensure their alignment before initiation. - Liaise with QA, Procurement, Planning, R&D, and other impacted teams to ensure smooth implementation. - Track and communicate status updates to stakeholders throughout the change lifecycle. - Monitor timely completion of assessments, reviews, approvals, and implementation tasks. - Send reminders and coordinate meetings to ensure due dates are met. - Manage amendments or extensions as needed, ensuring procedural compliance. - Maintain documentation and traceability to support internal and external audits. Qualifications Required: - Bachelor's degree in a related field such as Engineering, Life Sciences, or Information Technology. - Strong understanding of regulatory requirements in the Life Sciences industry. - Experience in utilizing change control management tools like COMET and Windchill. - Excellent communication and collaboration skills to work effectively with cross-functional teams. - Ability to prioritize tasks, manage timelines, and ensure compliance with established procedures.,