Label Craft, one of Ireland’s leading provider of labelling and packaging solutions to the medical and pharmaceutical products and medicines industry require the services of fully educated, trained and experienced pharmaceutical professional to act as Pharmaceutical Products Quality Regulatory Compliance Officer for our various pharma clients.
Full time permanent position.
Salary Euro 34,000 per annum, 39 hours per week.
www.label-craft.com
Main Duties will include:
Quality oversight for our medical labelling process and global labelling management systems.
Updating and managing of core labeling - Developmental Core Data Sheet (DCDS), Company Core Data Sheet (CCDS), Reference Safety Information (RSI), Investigatory brochures.
Review, update and manage submission ready labelling documents such as EU SmPC, Quality Review of Documents (QRD) or any regional labelling documents. Harmonizing content across all labeling documents.
Monitoring of Clinical overviews/ Justification documents that supports all mandatory statements for local labeling submission.
Label harmonization activities.
Comparison charts and alignment of CCDS with local Labeling documents. Readability testing (User testing) of PILs. Linguistic reviews and translations for all labeling documents.
QC/QA/proofreading of labeling and packaging.
Monitor regulatory intelligence related to labeling for country specific requirements.
Work with our IT, manufacturing and printing staff to ensure quality and compliance for Braille packaging and labelling designed for medicines packaging.
Requirements:
Must hold minimum degree or higher in the area of Pharma or Pharma Business Technology.
Must have work experience in the pharmaceutical industry or in the area of pharmacist.
Must be experienced in the area of Quality Control processes in healthcare products regulatory environment.
To apply post cv to: HR, Label Craft, Unit 10, Dundrum Business Park, Dundrum, Dublin, 14. Or email cv to marco@label-craft.com