QA Specialist
2 mesi fa
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 suppliers’ qualification in cooperation with the other company functions
- Acts as trainer in his/her area of responsibility/expertise
- As QA representative has the responsibility of ensuring the conformity to the regulatory requirements and to the applicable policies/procedures by taking part to the activities of both the validation and systems maintenance and through the internal audit to the different departments. Oversee the CAPA management process
PROFESSIONAL BACKGROUND & EXPERIENCE
- Bachelor Degree in Computer Science, Engineering, Life Sciences/Biomedical matters or Scientific Area
- At least 1 year of experience as CSV specialist in Life Science/Health industry,
KNOWLEDGE
- English, goog
- GXP regulations
- Quality Management System
- Document Management Processes
- Basic knowledge of computer information applicable regulation
- Basic knowledge of ISO/IEC 27001:2013 and of ISO 9001:2015
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Benefit:
- Computer aziendale
- Orario flessibile
Orario:
- Dal lunedì al venerdì
- Orario flessibile
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