Arithmostech
We areBusiness and Technology experts in the Life Sciences industry. We are along-standing Partner and Service Provider across Clinical Development,Regulatory and Compliance, Quality Management, Pharmacovigilance, and MedicalAffairs domains. We helppharmaceutical, biotechnology, nutraceutical, medical device, universities,hospitals and non-profit organisations to gain the best business value throughtechnology-enabled solutions and achieve excellence in business operations. Job Description PURPOSE: Collaborate with theQA personnel in all aspects of the Company Integrated Management System. Ensuresthat QA related documentation is properly archived . Requirements ACCOUNTABILITIES: Collaborate with the QATeam to ensure IMS maintenance and development to guarantee its efficiency andaudit/inspection readiness Manage clients’complaints from the receiving to the closure, in cooperation with Line Managers Oversee the deviationand incident management process from the registration through the analysis,action definition and closure Oversee the CAPAmanagement process Prepares and manages ofinternal, client and supplier audit, and prepare detailed reporting on theaudit results Manages ISM documents,organizing and managing the Archive Facilities applying quality principles ofarchiving (as Archive Manager) according to Arithmos policies and standardprocedures. Manages suppliers’qualification in cooperation with the other company functions Acts as trainer inhis/her area of responsibility/expertise AsQA representative has the responsibility of ensuring the conformity to theregulatory requirements and to the applicable policies/procedures by takingpart to the activities of both the validation and systems maintenance andthrough the internal audit to the different departments. BAKGROUND AND EXPERIENCE Bachelors Degree in LifeSciences / Biomedical matters or Masters in Quality Systems At least 2-3 years of experience as QAspecialist in Life Science/Health industry, GxP regulations Quality Management System ISO/IEC 27001:2013 and of ISO9001:2015 Computerinformation applicable regulation J-18808-Ljbffr
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