Global Quality Assurance Specialist

22 ore fa

Milano, Lombardia, Italia Alira Health Group A tempo pieno
Job Summary

We are seeking a highly motivated and detail-oriented Global Quality Assurance Specialist to join our team at Alira Health Group. As a Global Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and services.

Key Responsibilities
  • Tactical Responsibilities
    • Assist in the management and preparation of documents for electronic quality management systems (eQMS).
    • Support activities related to product and process change management.
    • Collaborate with the Product, Engineering, and Operations teams to ensure quality assurance activities and record creation align with internal quality management system (QMS) and information security management system (ISMS) procedures.
    • Participate in computer system validation activities by reviewing documentation and records.
    • Support the preparation and review of internal and external documents and reports required by Alira Health Group procedures.
    • Participate in or lead meetings as required.
  • Strategic Responsibilities
    • Maintain clear, regular, and professional communication with staff.
    • Respond to requests and emails promptly and efficiently.
    • Ensure adherence to and compliance with ICH GCP guidelines, FDA regulations, ISO standards, and company standard operating procedures (SOPs).
    • Escalate issues in a timely fashion.
    • Perform additional duties as assigned.
Requirements
  • Education and Experience
    • Bachelor's degree from an undergraduate program or equivalent experience in engineering, software development, or a related field.
    • General understanding of the pharmaceutical and biomedical industry and the clinical development process.
    • Basic understanding of regulations and guidelines relevant to the conduct of clinical investigations, such as ICH GCP.
    • Basic knowledge of standards and regulations relevant to medical devices, such as ISO 9001, ISO 13485, ISO 14971, ISO 27001, IEC 62304, IEC 62366, MDD, MDR, and 21 CFR 820.
    • Basic knowledge of the computer systems validation process and regulatory requirements relevant to the use of electronic records and signatures, such as 21 CFR Part 11.
    • Awareness of data protection laws and regulations, such as GDPR, CCPA, HIPAA, and EU Directives.
  • Skills and Abilities
    • Ability to be careful, thorough, and detail-oriented.
    • Ability to multi-task and work effectively in a fast-paced environment.
    • Fluent in English, both written and verbal; fluency in Italian and/or French a plus.
    • Good communication and interpersonal skills.
    • Proficient with MS Office Suite, particularly Word, Excel, PowerPoint, and SharePoint/Teams.
Working Conditions/Physical Demands
  • Normal office working conditions, including frequent sitting, standing, bending, twisting, and computer monitor use. Occasional lifting of weight up to 30 lbs.

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