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Qualified Person
Role Overview
Duties will include:
To represent the company to external authorities on liaison with MHRA with regards to product defect reporting
Manage the batch disposition process and file compilation
Oversee the systems and processes for the management of product technical complaints
Assist with the preparation, review and approval of quality agreements
Internal & external audits
Implement and maintain Standard Operating Procedures
Company Information
My client are a specialty vaccine company across several infectious diseases. They are soon to launching a new vaccination in the UK and the company has more than 700 employees across 6 countries.
Role Requirements
Excellent base salary
Company bonus
Stock options (LTI)
25 days holiday
Person Specifications
Eligible QP (UK qualified, under the Permanent Provisions)
Relevant experience of UK, EU and FDA cGMP requirements.
Good understanding and working knowledge of the Pharmaceutical Industry
Package
The Qualified Person will be overseeing the review, approval and certification of products, maintaining internal and external manufacturing testing activities whilst adhering to UK, EU and FDA regulatory requirements. This permanent position is based at my client’s location in Scotland.
Locations
We aim to operate and maintain the following set of core values