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Job Description

General position summary: The GDP Operational QA, Greece role will work with the International Quality to integrate Greek requirements into the global Quality Management System. The role will act as the quality representative within Vertex Greece and assume overall QA responsibilities for activities associated with the Greek affiliate. Additionally, the role supports commercial activities related to GDP and GMP.

Fluency in spoken and written Greek and English is essential.

This role reports to Associate Director, GDP Operational QA.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Responsible for the Quality oversight of repackaging/over-labelling activities at the 3PL ensuring compliance with local requirements
• Ensure that correct authenticity labels are applied on Vertex product distributed in Greece
• Act as the local quality representative for any quality issues impacting Greek market. Liaise with global Vertex QA partners on issue management and notifications to Health Authorities, as required.
• Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, local country manager.
• Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties.
• Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
• Ensure Quality Technical Agreements are in place for all outsourced activities
• Support recall operations for Vertex
• Escalate quality issues to senior management as per Vertex procedures
• Input into the International Quality Management review process
• Work with the GDP Operational QA team to ensure the requirements of the Greek guidelines are integrated into the global QMS. This will include:
  • Change Control
  • Deviation Management
  • Training, including training materials
  • Document Control, including SOPs, WIs, Site Master Files and forms
  • Risk Management
  • Management Review
  • Self-Inspection/Internal Audit
  • Vendor Management
  • Customer Qualification
  • Complaints, Returns, Falsified Medicines and Recalls
  • Regulatory Intelligence
  • Promotional Material and Healthcare Professional communications oversight.

Minimum qualifications:

• Master’s degree or relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and extensive relevant work experience, or relevant comparable background
• Ability to travel up to 10% of the time

Preferred Qualifications:

• Knowledge of International GDP regulations; GMP and GVP regulations as a preference.
• Previous experience acting as a Responsible Person on an EU Wholesale Dealers Authorisation.
• Previous GDP auditing experience, GMP experience preferable.

• Ability to collaborate cross functionally across all levels of the organization
• Risk-based thinking
• Strategic thinking / forward thinking / planning
• Technical writing

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