Quality Assurance Specialist

We are Business and Technology experts in the Life Sciences industry.

We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations. We are a long-standing partner and service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.

PURPOSE:

Collaborate with the QA personnel in all aspects of the Company Integrated Management System. Ensures that QA related documentation is properly archived.

ACCONTABILITIES:

• Collaborate with the QA Team to ensure IMS maintenance and development to guarantee its efficiency and audit/inspection readiness
• Manage clients’ complaints from the receiving to the closure, in cooperation with Line Managers
• Oversee the deviation and incident management process from the registration through the analysis, action definition and closure
• Oversee the CAPA management process
• Prepares and manages of internal, client and supplier audit, and prepare detailed reporting on the audit results
• Manages ISM documents, organizing and managing the Archive Facilities applying quality principles of archiving (as Archive Manager) according to Arithmos policies and standard procedures.
• Manages suppliers’ qualification in cooperation with the other company functions
• Acts as trainer in his/her area of responsibility/expertise

Profilo

BACKGROUND & EXPERIENCE

• Bachelors Degree in Life Sciences / Biomedical matters or Masters in Quality System
• At least 3 years of experience in Quality Assurance
• English good
• GxP regulations
• Quality Management System
• Basic Knowledge of ISO/IEC 27001:2013 and of ISO 9001:2015
• Basic Knowledge of computer information applicable regulation