Quality Assurance Manager

Excellent Career Opportunity, to Join a Leading Manufacturer, Wholesaler and Exporter of Branded Generic Medicines and Healthcare Products, who have a Vacancy for a Quality Assurance Manager to Oversee the Full QA Operations Activity

ROLE

• Management of the QA Operations Function and Resources
• Responsibility for Ensuring that Lifecycle Management of the Products is Maintained, from Supporting the New Product Introduction Process to Any Changes Made to the Product
• Responsibility for the Full Batch Certification Process, Ensuring that Batches are Manufactured in Accordance with GMP, Tested Against Correct Specifications and Methods in EU and UK Laboratories and Batch Release Files Provided to QPs for Batch Certification Prior to Batch Release for Sale
• Preparing, Documenting and Filing Change Controls Regarding Batch Certification Activities
• Development and Preparation of Documentation for the Quality Management Systems
• Produce Status Reports for Activities Related to Batch Certification
• Liaising with all Contract Manufacturing Organisations and Qualified Persons, to Receive and Ensure Review is Completed for the Necessary Documentation and Related Records
• Organising EU Import Testing and Liaising with the Laboratory Accordingly, Including Ensuring Analytical Method Transfers and Microbial Method Transfers are Performed Satisfactorily
• Maintaining Masterfile’s eg Stability Reports, Validation Reports etc
• Preparation and Completion of Supply Chain Diagrams and Annual Product Quality Reviews for All Relevant Products

REQUIRED (Essential)

• Relevant Degree in a Life Science Discipline
• Proven Experience in Quality Assurance within the Pharmaceutical Industry
• Experience Managing a Large Team
• Working Knowledge and Practical Experience with Document Controls, Change Controls and Deviations

REQUIRED (Preferable)

• Experience of Working with Contract Manufacturing Organisations, Importation and Batch Certification

REMUNERATION

• £55K, Subject to Qualifications and Experience

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV