Direct message the job poster from Blackfield Associates
Lead Quality Assurance Consultant – United Kingdom & Ireland
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
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Transportation, Logistics, Supply Chain and Storage
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