In sintesi
- Mansioni: Pianifica e conduci audit GCP per garantire la conformità normativa in tutta Europa.
- Azienda: IQVIA, leader globale nella ricerca clinica con un ambiente dinamico.
- Benefit: Salario competitivo, benefit sanitari, opportunità di viaggio e sviluppo professionale.
- Altre informazioni: Ambiente stimolante con opportunità di crescita e formazione continua.
- Perché questo lavoro: Contribuisci a migliorare la ricerca clinica e fai la differenza nel settore sanitario.
- Qualifiche: Certificazione per condurre audit e 5 anni di esperienza nel settore farmaceutico.
La retribuzione prevista è compresa tra 72000 - 88000 € per anno.
Overview
As a Quality Assurance Auditor, you will plan and conduct independent GCP audits across IQVIA contracts in Europe to verify regulatory and procedural compliance.
You will produce findings reports for stakeholders and help customers interpret regulations and policies.
You will support continuous process improvements, maintain the e QMS, and lead QA initiatives, including training staff and guiding corrective actions.
This role blends audit execution with advisory support to project teams and customers, contributing to reliable, compliant clinical research operations.
You will operate in a fast-paced, cross-functional environment with travel to sites across Europe, starting from Milan.
- Retribuzione / Benefits
- health and welfare benefits
- potential bonuses or incentive plans
- career development and training opportunities
- travel opportunities across Europe
- structured onboarding and ongoing education
- work in a leading global clinical research organization
- Responsabilità
- Plan, schedule, conduct, report and close audit activities across involved countries to assess compliance with regulations, guidelines, customer requirements, IQVIA SOPs and project guidelines
- Evaluate audit findings and prepare/distribute reports to operations staff, management, and customers
- Provide interpretation and consultation to project teams on regulations, compliance status, and policies
- Consult with customers and monitors on interpreting audit observations and corrective action plans
- Review/approve investigations, RCA, CAPA and EC plans; track closure for quality events from audits or QA activities
- Evaluate policies/procedures for regulatory compliance and recommend process improvements
- Maintain the electronic quality management system (e QMS) and support audit lifecycle
- Lead/collaborate/support QA initiatives/projects for quality and process improvements
- Assist in training of new Quality Assurance staff
- May manage Quality Issues and present educational programs on compliance procedures
- May conduct pre-inspection visits, host audits/inspections, and assist in regulatory facility inspections as assigned
- Requisiti fondamentali
- Certified to conduct audits in Italy per Italian Decree of the Ministry of Health (dated 15 Nov 2011)
- Travel 30-50% mainly in Europe
- 5 years experience in pharmaceutical/technical field, with 3 years in Quality Assurance Audits
- Experienced in conducting clinical trial Investigator site audits
- Experience in clinical study report/data management audits preferred
- Knowledge of word-processing, spreadsheet, and database applications
- Extensive knowledge of pharmaceutical R&D processes and regulatory environments
- Knowledge of quality assurance processes and procedures
- Strong interpersonal, problem solving, risk analysis, and negotiation skills
- Strong training, organization, communication, and team orientation skills
- Ability to work independently and manage multiple projects
- Ability to establish and maintain relationships with coworkers, managers and clients
- strong interpersonal skills
- excellent problem solving and negotiation
- effective training capabilities
- word-processing
- spreadsheets
- databases
Senior QA Auditor - GCP Audits datore di lavoro: IQVIA
IQVIA è un datore di lavoro eccezionale, offrendo un ambiente di lavoro collaborativo e multiculturale che promuove la crescita professionale e lo sviluppo delle competenze. I dipendenti hanno l'opportunità di affrontare sfide significative nel settore delle scienze della vita, lavorando a stretto contatto con leader del settore e contribuendo a progetti innovativi che migliorano i risultati per i pazienti. Inoltre, IQVIA valorizza il mentoring e la costruzione di capacità tra i membri del team, rendendo ogni giorno un'opportunità per apprendere e crescere.
