QA Officer
Smart4Sciences
- Knutsford, England, United Kingdom
- Knutsford, England, United Kingdom
Über
This is a key role within the QHSE department, supporting the ongoing development and maintenance of a robust Quality Management System (QMS) in line with GMP, ISO 9001, and ISO 14001 standards.
About the Role
As a Quality Assurance Officer, you will play a critical role in ensuring product quality, regulatory compliance, and continuous improvement across the site. You will work closely with cross-functional teams including production, QC, and technical departments to maintain high standards of compliance and operational excellence.
You will be involved in document control, deviation management, CAPA systems, internal audits, and regulatory inspection support, helping to drive a strong culture of quality and accountability.
Key Responsibilities
Support the maintenance and continuous improvement of the Quality Management System (QMS) Review, author, and update SOPs, specifications, and controlled documents Manage deviations, CAPAs, change controls, OOS/OOT investigations, complaints, and recalls Support and participate in internal and external audits Assist in preparation for regulatory inspections (e.g. MHRA, ISO audits) Maintain training records and site-wide training matrices Support quality metrics, KPI reporting, and trend analysis Ensure accurate document control, archiving, and compliance systems Contribute to continuous improvement initiatives across the business
Essential
A degree in a scientific or related discipline, or equivalent relevant industry experience Strong working knowledge of Good Manufacturing Practice (GMP) within a regulated environment Hands-on experience with Quality Management Systems (QMS) Practical experience in key QA processes including document control, deviations, CAPA, and change control Experience supporting or preparing for internal and external audits / regulatory inspections
Desirable Experience
ISO 9001 / ISO 14001 exposure Internal auditing experience GMP/QMS auditing certification
Sprachkenntnisse
- English
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