Quality Assurance SpecialistBlackfield Associates • London, England, United Kingdom
Quality Assurance Specialist
Blackfield Associates
- London, England, United Kingdom
- London, England, United Kingdom
À propos
Blackfield are partnered with a dynamic, high-growth pharmaceutical organisation in the search for a Quality specialist based in Surrey. The Quality Systems Specialist will play a key role in supporting the operational implementation and continuous improvement of the Quality Management System, ensuring compliance with GDP and/or GMP requirements. This role focuses on managing Change Controls, Deviations, and CAPA processes, while also contributing to other QA system activities when required. The successful candidate will act as a subject matter resource for quality event management, document control, and quality metrics, working closely with cross-functional teams to drive compliance and process improvement. Key Responsibilities: Manage Change Controls as owner, overseeing risk assessments, stakeholder coordination, approvals, and closure in line with ICH Q9 principles and internal SOPs. Support quality event management, ensuring deviations, CAPAs, and change controls are initiated, investigated, documented, and closed within agreed timelines. Oversee QA-controlled documentation, including SOPs, Work Instructions, and Forms, ensuring correct lifecycle workflows, training compliance, and document control in Veeva Vault. Prepare and analyse Quality Metrics and KPIs for Deviation, CAPA, and Change Control processes, contributing to trend analysis, Quality Review Meetings, and Management Reviews. The ideal candidate will hold a degree in a Life Sciences discipline (or equivalent experience) and have 3–5 years’ experience in a GxP-regulated pharmaceutical environment. They will demonstrate strong knowledge of EU GDP/GMP guidelines, experience managing quality system processes, and proficiency with electronic QMS platforms such as Veeva Vault, Q-Pulse, etc. Exceptional attention to detail, problem-solving skills, and the ability to work independently in a fast-paced environment are essential. If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
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Compétences linguistiques
- English
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