Sr. Qa Auditor, Gcp
6 giorni fa
Job Overview Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.Prepare and distribute reports of findings to supervisor, operations staff, management, and customers.Provide consultation in interpretation of regulations, guidelines, policies, and procedures.Support management in promotion and assessment of compliance to regulations, guidelines, and corporate policies.Essential FunctionsPlan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.Manage Quality Issues.Present educational programs and provide guidance to operational staff on compliance procedures.Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.Provide quality assurance consultancy activities and projects for clients within budget and established timelines.Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.Host audits/inspections.Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.May perform GLP Archivist duties where needed.Manage/oversee quality events updates in eQMS and maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.Lead/collaborate/support in QA initiatives/projects for quality, process improvements.Assist in training of new Quality Assurance staff.QualificationsAbility to travel *****% across Europe.10 years experience in pharmaceutical, technical, or related area, of which 5 years in Quality Assurance.GCP audit experience is a must.Knowledge of word-processing, spreadsheet, and database applications.Extensive knowledge of pharmaceutical research and development processes and regulatory environments.Knowledge of quality assurance processes and procedures.Excellent problem solving, risk analysis and negotiation skills.Strong training capabilities.Effective organization, communication, and team orientation skills.Ability to initiate assigned tasks and to work independently.Ability to manage multiple projects.Ability to establish and maintain effective working relationships with coworkers, managers and clients.This role is not eligible for UK Visa sponsorship.#J-*****-Ljbffr
-
Sr. Qa Auditor, Gcp
6 giorni fa
Bardi, Italia Iqvia A tempo pienoOverviewPlan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures.Prepare and distribute reports of findings to supervisor, operations staff, management, and customers.Provide consultation in interpretation of regulations, guidelines, policies, and procedures.Support management in promotion and assessment...
-
Senior Gcp Qa Auditor — Compliance
6 giorni fa
Bardi, Italia Iqvia A tempo pienoA leading global healthcare data and analytics firm in Milano is seeking an experienced Quality Assurance Manager for compliance audits.The role includes planning and conducting independent audits, preparing reports, and providing consultations on regulatory guidelines.Candidates should have 10 years of experience in the pharmaceutical sector, with a focus...
-
Senior Gcp Qa Auditor
6 giorni fa
Bardi, Italia Iqvia A tempo pienoA leading global provider of advanced analytics seeks an experienced Quality Assurance professional for auditing and compliance assessments.Ideal candidates must possess at least 10 years of experience in the pharmaceutical field, with a minimum of 5 years specifically in Quality Assurance.Responsibilities include conducting independent audits, managing...
-
Qa Document Compliance...
19 ore fa
Bardi, Italia Manpower A tempo pienoManpower Lifesceince ricerca un/a QA Document Compliance Specialist Sede di lavoro: Sud Milano----------------------------------------Missione del RuoloLa figura sarà responsabile della gestione del sistema documentale aziendale, garantendo la conformità ai requisiti normativi e agli standard di qualità, sicurezza e sostenibilità.Il ruolo supporta i...
-
Specialista Hse
4 giorni fa
Bardi, Italia Applus Europe A tempo pienoInformazioni sull'aziendaApplus+ è una delle aziende leader a livello mondiale nel settore dell'ispezione, dei test e della certificazione.L'azienda è composta da un team diversificato e multidisciplinare di oltre ****** professionisti con competenze riconosciute e capacità uniche, noti per la loro eccellenza tecnica in vari settori.Informazioni sul...
-
Programmatore Python Backend
6 giorni fa
Bardi, Italia Dieffetech S.R.L. A tempo pienoHai passione per il codice pulito, le architetture scalabili e vuoi lavorare su progetti stimolanti in un ambiente dinamico?Stiamo cercando uno sviluppatore backend Python da inserire nel nostro team di sviluppo!Chi cerchiamo:Un professionista con una solida esperienza nello sviluppo backend, orientato alla qualità del codice e alla collaborazione con gli...
-
Industrial Services Inspector: Certification
4 minuti fa
Bardi, Italia Rina A tempo pienoA multinational company in Italy is seeking an experienced inspector to ensure the safety and quality of industrial services. The ideal candidate will conduct on-site inspections, prepare reports, and monitor compliance with regulatory standards for welding and pressure equipment. You should possess a Bachelor’s Degree in Engineering or ASME Inspector...
-
Biostatistician Sr. Specialist
5 giorni fa
Bardi, Italia Altro A tempo pienoJoin to apply for the Biostatistician Sr.Specialist role at ZambonZambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people's health and patients' lives.Based on a valuable heritage but strongly focused on the future, its Vision is "Innovating cure and care to make patients' lives better".Zambon...
-
Quality Advisor
1 settimana fa
Bardi, Italia Carlo Gavazzi Impianti A tempo pienoPer la nostra sede di Assago (MI) stiamo selezionando un* Quality Advisor che fungerà da supporto all'RSPP e QHSE Manager per il raggiungimento degli obiettivi della Società ed il Team HSE & QA/QC che si sviluppano partendo dagli obblighi legislativi previsti dal D.Lgs. ******* (Salute e Sicurezza) e dal D.Lgs. ******** (Ambiente), e dalle Normative...
-
Quality Advisor
1 settimana fa
Bardi, Italia Carlo Gavazzi Impianti A tempo pienoPer la nostra sede di Assago (MI) stiamo selezionando un* Quality Advisor che fungerà da supporto all'RSPP e QHSE Manager per il raggiungimento degli obiettivi della Società ed il Team HSE & QA/QC che si sviluppano partendo dagli obblighi legislativi previsti dal D.Lgs. ******* (Salute e Sicurezza) e dal D.Lgs. ******** (Ambiente), e dalle Normative...
