Job Reference: 23311
Job Duration:
Start date: ASAP
Description:
Candidates wishing to apply will need to promote a culture of quality excellence and ensure that our client is compliant with all regulatory requirements and legislation in the activities of the UK business.
To promote a culture of Quality excellence
To ensure our client is compliant with all regulatory requirements and legislation in the activities of the UK business.
To ensure all activities, processes and procedures are carried out to the highest quality and accuracy standards.
To ensure full GMP, GDP and GCP compliance of the business.
To conduct external auditsof existing contract manufacturers and suppliers and conduct vendor assessment/selection for all
new manufacturers, suppliers and providers.
To investigate alongside the EU QP and in accordance with written procedures, all complaints relating to the quality of the products and if substantiated to initiate action to prevent recurrence.
To host/support Regulatory Authority Inspections.
To review batch certification and manage other available QP resources, ensuring all Regulatory documents are available andbcurrent to support certification.
To manage the tech-transfer of new products, from the preparation and review to thetransfer of protocol
To develop and maintain governing standards.
To act as a Responsible Person as per requirements of the WDA(H), ensuring that the conditions of the licence are met and the guidelines of GDP are complied with.
To approve specifications, sampling instructions, test methods and QC procedures, including amendments.
To review and evaluate all completedmanufacturing and packaging documents to ensure that each batch has been produced tested and packed in accordance with the directives and the marketing authorisation.
To prepare and review Annual Product Quality Reviews.
To approve and monitor suppliers of raw materials and packaging components.
To ensure the establishment of the validation of all analytical methods.Candidates wishing to apply will be coaching and developing direct reports, so excellent communication skills are a must.
Industry: Pharmaceuticals
Salary: £80000 - £120000 per annum + Additional Benefits
Salary Benefits: Additional Benefits
Vacancy Type: Permanent
Job Skills: Quality Assurance/ Head of Quality/Quality & Compliance
Contact Name: Tim Barratt
Website: -
Direct Application URL: -