Quality Assurance Officer

About the role

We are seeking a Quality Assurance Officer to join a fast‑paced pharmaceutical manufacturing organisation in Knutsford. The role is central to the QHSE department, supporting the development and maintenance of a robust Quality Management System that meets GMP, ISO 9001 and ISO 14001 standards.

Key responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Author, review and update SOPs, specifications and controlled documents.
• Manage deviations, CAPAs, change controls, OOS/OOT investigations, complaints and product recalls.
• Support and participate in internal and external audits, including preparation for MHRA and ISO inspections.
• Maintain training records and site‑wide training matrices.
• Produce quality metrics, KPI reporting and trend analysis.
• Ensure accurate document control, archiving and compliance systems.
• Contribute to continuous improvement initiatives across the business.

Required profile

• A degree in a scientific discipline or equivalent industry experience.
• Strong working knowledge of Good Manufacturing Practice (GMP) in a regulated environment.
• Hands‑on experience with Quality Management Systems (QMS).
• Practical experience in document control, deviations, CAPA and change control.
• Experience supporting internal and external audits or regulatory inspections.

Required skills

• Good Manufacturing Practice (GMP)
• Quality Management Systems (QMS)
• Document control
• Deviation and CAPA management
• Change control processes
• Internal audit preparation
• Regulatory inspection support (e.g., MHRA)
• ISO 9001 and ISO 14001 familiarity