JOB DESCRIPTION / ROLE
Our client, a global pharmaceutical giant is now on the search for a labeling - Artwork specialist to be employed in their Drug & regulatory affairs department.
The responsibilities include the following:
• Act as advisory to Medical Device clients and project teams delivering labeling services
• Provide technical Device Labeling Artwork, print production, Change Notices, globally.
• Proofs, edits, and manages labeling documents.
• Updates designated databases/ internal sites containing department information according to standard operating procedures (SOPs).
• Tracks correction and preventative actions (CAPAs) and department metrics
• Provides summary reports to department management and designated stakeholders.
REQUIREMENTS
What we are looking for, is a candidate who demonstrate expertise in the following:
• Graphic, Print design, and Print systems (Adobe Suite (Illustrator, InDesign, Photoshop), Bartender, Label view, Code Soft, Prysm, etc.)
• Excellent oral and written communication skills
• Excellent attention to detail
• Knowledge of Medical Device Quality System Regulations & QMS:
• (FDA 21CFR Part 820, ISO 13485, GDP)
• Medical Device Regulation [EU MDR 2017/745]
• Knowledge of EU Medical device regulation like o Medical Device Directive 93/42/EEC
• Experience in the review and approve advertising and promotional materials (US, EU and Global) a plus
• Excellent written (Technical Writing) and Verbal communication skills
• Good knowledge of Materials, Manufacturing process and capabilities
• Ability to identify Compliance Risks and Escalate when necessary.
• Change control Process
• The ideal candidate will have nearly 3 years of experience with a Bachelors Degree in relevant field of Study
ABOUT THE COMPANY
Transguard Workforce Solutions delivers Professional Contract Staffing (also known as Employee Outsourcing) within the UAE.
Our Workforce Solutions include:
• Delivering Sourcing and Recruitment Solutions for Clients in need of identifying Contract or temporary Staff.
• Providing a complete end to end Staffing Solution which includes Visa Sponsorship, HR Management, Employee Welfare & Payroll Services.
• Transitioning Contract Staff from other staffing providers to Transguard while remaining compliant with UAE Labour and Immigration Laws.
Transguard Workforce Solutions currently employ over 2000+ Staff from over 70 different nationalities. Across the Group, we payroll over 70,000 employees monthly.
