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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 bonus
Stock options (LTI)
25 days holiday
Relevant experience of UK, EU and FDA cGMP requirements.
Good understanding and working knowledge of the Pharmaceutical Industry
The role is covered in the following locations: Edinburgh
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 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
Key Duties and Responsibilities
Excellent base salaryCompany bonus
Stock options (LTI)
25 days holiday
Person Specification
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 clients location in Scotland.
01 Oct 2023
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