Regulatory Compliance Expert

19 hours ago


Addlestone, Surrey, United Kingdom Astellas Full time
Astellas Job Opportunity
We are seeking a highly motivated and organized individual to join our team as a Quality Assurance Specialist. In this role, you will support the Responsible Person Import (RPi) and the QA Lead in meeting their responsibilities and accountabilities. You will independently complete standard quality assurance activities in the affiliate, performing and processing tasks governed by Good Distribution Practice Guidelines (GDP Guidelines). The role requires a blend of home and office work, with flexibility needed to meet business needs.

Responsibilities
  • Perform and process activities that are governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the (global) Quality Management System.
  • Support with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls.
  • Represent Affiliate QA in recurrent, local, and global project teams, such as workflow training, onboarding training.
  • Act as a role model for the Quality Culture in the affiliate.

Requirements
To be successful in this role, you will need:
  • Degree in a science/health-related subject or equivalent.
  • Possess relevant transferable skills in a comparable role in the pharmaceutical industry.
  • Have an understanding of implementation and understanding of GDP, GMP, and Quality Management Systems.
  • Good organizational, coordination, presentation, and communication skills.
  • Experience with Trackwise (Digital), Veeva, and SAP systems (preferred).
  • Knowledge of handling regulatory interfaces such as inspections and audits (preferred).

Salary Information
The salary range for this position is $70,000 - $90,000 per year, depending on location.

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