Details:
- Location: Knutsford Cheshire
- Date: 1 month ago
Description:
We are currently recruiting for a Quality Assurance Officer to join a fast-paced pharmaceutical manufacturing organisation committed to delivering high-quality, safe, and compliant products including unlicensed medicines and NHS-approved disinfectants.
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