Job Summary
The Artwork Specialist/Senior Specialist plays a crucial role in managing artwork updates, ensuring timely compliance with regulatory implementation deadlines and supply requirements. This position requires effective communication with internal and external stakeholders to ensure clear project goals and timelines.
Key Responsibilities
* Initiate artwork changes in the company's artwork management system (GLAMS) based on notifications of regulatory approval and/or project schedules.
* Coordinate artwork changes through input, creation/update and approval with relevant internal and external functions.
* Coordinate requests for mock-ups to support submissions to regulatory authorities.
* Manage implementation timelines for artwork changes, including agreeing requirements with Regulatory Affairs, planning and managing projects, and liaising with stakeholders.
* Ensure artworks are approved and released on time to meet implementation requirements.
Quality, Compliance & Continuous Improvement
* Proactively engage within the department to improve and maintain compliance and audit-ready status.
* Work cross-functionally to identify process improvement areas.
* Ensure procedures are compliant and followed.
* Prepare and update documentation/procedures, as required, for compliance and continuous improvement projects.
* Actively participate in system upgrade/process improvement projects.
Requirements
* A relevant science/engineering bachelor's degree preferred and/or equivalent work experience.
* 2 years administration/artwork coordination experience, preferably in the pharmaceutical industry.
* Detail and technical oriented, focused on accuracy.
* Analytical thinker with excellent problem-solving skills.
* Intellectual curiosity – willing to learn, as well as to suggest and try new ideas.
* Takes ownership and accountability for activities.
* Positive and proactive approach to business tasks.
* Excellent verbal and written communication and skills.
* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment.
* Excellent planning, organization and time management skills.
* Sense of urgency – responding to issues and opportunities in a timely manner.
* Ability to manage multiple artwork change projects whilst ensuring compliance and supply-to-market requirements are always met.
* Experience of working in accordance with quality standards, e.g. GMP.
* Experience of using a quality management system preferred.
* Demonstrated ability to establish and maintain effective working relationships with internal team members and external vendors.
* Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business.
* Proficiency with Microsoft Office.