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Quality assurance specialist

Twickenham
Permanent
Quality assurance specialist
£35,000 a year
Posted: 30 May
Offer description

An excellent opportunity has arisen for an experienced Quality Assurance Specialist to join our client based in South West London on a permanent basis. The ideal applicant will have an in depth pharmaceutical background with a strong knowledge of QMS, EU/UK GMP and EU/UK GDP guidelines. Spanish language skills are essential, at a professional level. Responsibilities Include: Ensure Quality Assurance (QA) business and regulatory requirements are met at all times by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in the clients GMP and WDA licences. Co-ordinate the collation and review of supplier licences and certificates. Ensure medicinal products procured, held and distributed are as authorised by WDA of company, storage premises and customers. Manage authorised activities to ensure operations do not compromise the product quality and remain in compliance with GDP & GMP. Ensure that any additional requirements imposed on certain products by national law are adhered to e.g. specials, medical devices, unlicensed imports, parallel imports and controlled drugs where applicable to the WDA & MIA. Co-ordinate the collation and review of product quality documentation and technical data in order to check that products remain safe, compliant and of a high standard for supply. QMS Management; management of the clients QMS, ensuring measures are in place to support good documentation practice and data integrity principles and an awareness of new, and revisions to existing quality directives within EU guidelines. Operational management; Monthly KPIs for batch release performance monitoring, batch release co-ordination for MIA products, sample management and site of importation performance monitoring. Qualifications: Degree level in a Life Science subject or equivalent in relevant experience. Knowledge of Quality Management system within a pharmaceutical background. Good understanding of GMP / GDP. Good understanding of pharmaceutical regulation and regulators. Good inter-personal and communication skills. Ability to work under pressure and to tight time deadlines. Excellent attention to detail. Ability to prioritise work. Effective time management. High level of IT skills. Relevant knowledge and experience related to the distribution of medicinal products. Able to communicate effectively in English and Spanish for technical discussions.

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