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Labeling lead- Drug regulatory affairs

Transguard group

Posted on October 22, 2019

2 - 5 years AED 10,000 - 20,000 ($2,700 - $5,400) Dubai - United Arab Emirates

Any Graduation. Any Arabic National, Any GCC National

Insurance + Yearly flight tickets

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Job Description

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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.


Production / Manufacturing

Desired Candidate Profile

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

Keywords

Drug Regulatory Affairs Quality Assurance Artwork Labels Production Manufacturing

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Transguard group

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 compl ete 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 1300+ Staff from over 70 different nationalities.
Across the Group, we payroll over 48,000 employees monthly and provide 3 Year Immigration Visas.
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