Senior Quality Assurance Associate; SQAA

Job Title:
Senior Quality Assurance Associate

Department:
Quality Assurance

Reporting to:
Quality Assurance Manager

Working Hours:

37.5 hours/week (flexible + remote by agreement)

Holiday Entitlement: 25 days + bank holidays

You will manage and maintain the Quality Management System (QMS), ensuring inspection readiness at all times. You will also support the Head of Quality Control and the Responsible Person for MHRA‑licensed activities.

• Ensure effective management of quality systems and support inspections by auditors, MHRA, and the Home Office.
• Support preparation for regulatory licence approvals.
• Manage and execute Change Controls, Incidents, Deviations, Complaints, CAPAs, and Risk Assessments as Owner/Approver.
• Execute Internal Audits in line with the audit schedule.
• Support Vendor and Customer Qualification programmes, including audits.
• Support Qualification & Validation activities as an Owner.
• Support generation of Quality Metrics and performance against KPIs.

• Ensure compliance of supply chain for imported product in line with regulatory standards and MHRA expectations.
• Ensure GDP‑compliant importation of products.
• Perform bona fide checks of suppliers and customers.

• Write protocols, reports, presentations, procedures, forms and policies.

• Promote a positive culture of quality and compliance.
• Deliver QMS training and ongoing GxP training.

• Review and approve finished batch manufacturing/packaging records.
• Perform delegated product release under Manufacturer’s Specials GMP licence.
• Approve release under the Wholesaler Distribution Authorisation (GDP) licence.
• Develop and enhance QMS activities related to product release.
• Drive continuous improvement across the organisation.