Associate Director QP, EU Batch Release

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Beschrijving

As an Associate Director QP, you will be an integral part of the Quality team, responsible for the management of all GMP aspects, bringing your expertise to support the business. You will be hands-on as well influencing quality strategy. Your responsibilities will include:
• EU Batch Release, ensuring compliance and maintaining processes for batch certification
• GMP Compliance support, including internal auditing as well as vendors
• Review and approval of internal and external GMP Deviations and CAPAs
• Ensuring new and upcoming GMP requirements are incorporated into the QMS
• Providing Q&A advice to other functions
• Regulatory Authority Interactions and Inspection Management
• Supporting local, regional and global QA and Supply Chain projects

We are looking you to utilise your GMP expertise as well be strategic thinking, be passionate about improving patients’ life’s and have can do attitude, as well as:
• Have previously been named ‘Qualified Person as defined in 2001/83/EC and 2001/82/EC on a MIA
• GMP QA experience, including IMPs, APIs, Bulk, Packaging and Analytics
• Knowledge of the principles and guidelines for GMP as set out in: ” EU “Eudralex Volume 4”
• Fluency in English, oral and written
• Flexibility and ability to adapt to changing conditions

Solliciteer op: Associate Director QP, EU Batch Release

CV & Motivatie (max. 3 bestanden: doc, docx, pdf, jpg)
Are you currently a Qualified Person (QP) who wishes to have more responsibility and a greater breadth of duties in your role? Please apply now!