QA Specialist Senior
Manpower
Tivoli Terme
20
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Azienda: Manpower Tivoli Terme
In this role you will be responsible for ensuring compliance and efficiency across affiliate's quality activities related to pharmaceutical products, medical devices, combination products, and biologics.
This includes areas such as Storage and Distribution, quality events/product shortages, Supplier Controls, Product Quality Review, Risk Management, inspections/audits, CAPA, and overall Quality Manual requirements.
Job Core Responsibilities Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
Plan, prepare, review and approve quality documentation such as change controls, product reviews and other local requirements.
Support internal, external and MoH audits as directed by the manager, lead self inspections.
Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
Execute supplier qualification program including performance monitoring for key suppliers.
Monitor metrics and KP Is to ensure compliance.
Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management.
Preferred Knowledge and Experience Bachelor's Degree in a technical/scientific field; 3+ years experience in quality assurance, GMP or GDP environment; Proficiency in computer skills (SAP, Track Wise, Compliance Wire, and One Vault) Full understanding of local GxP requirements and regulations.
Requisiti Bachelor's Degree in a technical/scientific field; 4+ years experience in quality assurance, GMP or GDP environment; Codice annuncio: 759063 Data di pubblicazione: 11 ottobre 2024 Tipologia di assunzione: Assunzione Diretta Industria: Chimico- Farmaceutico Validità annuncio fino a : 31 ottobre 2024 Posizioni ricercate: 1 Da Remoto: No Full-time/ Part-time: Full time Tutte le aree funzionali: controllo qualità Opportunità Green: No
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