Quality Assurance Specialist

Quality Assurance Specialist

Leveraging Our Expertise in Quality Management

We are seeking a skilled Quality Assurance Specialist to support the implementation and maintenance of our Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, ensuring compliance with EU GDP guidelines.

Key Responsibilities:

• Maintaining and Enhancing the QMS: Uphold regulatory, ISO, and client requirements by implementing process improvements and best practices.
• SUPPORTING AUDITS AND CAPA PLANS: Collaborate on audits (regulatory, ISO, client, supplier) and manage corrective action plans to ensure quality excellence.
• Driving a Culture of Excellence: Foster a culture of quality awareness across the business through education, training, and coaching.
• Conducting Supplier Audits and Inspections: Verify compliance with regulatory requirements, conduct internal inspections, and participate in management reviews.

Key Requirements:

• Proven Experience in Regulated Environments: Possess experience in GMDP or similar regulated environments.
• Comprehensive Knowledge of Regulations: Strong understanding of GDP, GMP, ISO 9001, and ISO 13485 standards.
• Exceptional Organisational Skills: Demonstrate excellent organisational, communication, and stakeholder management skills.
• Positive Attitude towards Quality: Show a strong commitment to promoting quality awareness across all departments.
• Proficiency in Microsoft Office Applications: Proficient in MS Office applications (Word, Excel, PowerPoint, Teams).