Quality Assurance Specialist

1 Tech Staffing Ltd; Leighton Buzzard; On-site; GBP 35,000 - 40,000; Full time

Job summary

A leading pharmaceutical logistics company is seeking a Quality Assurance Specialist in Leighton Buzzard. The role involves maintaining the Quality Management System in compliance with ISO standards and EU GDP guidelines. Ideal candidates will possess strong knowledge of regulatory requirements and excellent communication skills.

Qualifications

• Proven experience in a GMDP or similar regulated environment.
• Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards.

Responsibilities

• Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements.
• Supporting audits and managing CAPA plans.
• Driving a culture of quality excellence across the business.

Skills

Organizational Skills

Communication

Stakeholder Management

Positive Attitude

Tools

MS Office

Job description

Quality Assurance Specialist
Leighton Buzzard, Bedfordshire

35,000 - 40,000

We are seeking a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines.

Key Responsibilities:

• Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements.
• Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans.
• Driving a culture of quality excellence across the business.
• Conducting supplier audits, internal inspections, and management reviews.

Key Requirements:

• Proven experience in a GMDP or similar regulated environment.
• Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards.
• Excellent organizational, communication, and stakeholder management skills.
• A positive attitude toward promoting quality across all departments.
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Teams).

If you have the skillset required and looking for your next career move, please apply for immediate consideration.