Qa cleaning validation

Il candidato riportando al QA manager si dovrà occupare di: Cleaning Valdation: Preparare valutazioni, protocolli o altri documenti relativi alla convalida della pulizia Sviluppare o modificare i SOP correlati Condurre valutazioni interne sulle prestazioni e sulla conformità del programma di convalida delle pulizie Garantire la pianificazione e l'esecuzione delle attività di campionamento Creare e gestire un database per il monitoraggio delle attività di convalida Process Validation: Studiare le caratteristiche del prodotto e del processo Rivedere le strategie di validazione e la documentazione associata Preparare protocolli di validazione per formule, processi di produzione, sistemi e apparecchiature nuovi e modificati Assistere nella formazione di operatori e altro personale sui protocolli di validazione e SOP Preparare report dettagliati basati sui risultati dei test di validazione e qualificazione Implementare e pianificare i test di validazione Rispettare i requisiti interni e normativi Creare e gestire un database per il monitoraggio delle attività di convalida Identificare le deviazioni dagli standard di prodotto o di processo stabiliti Gestione di Deviazioni ed Eventi Atipici Stesura Report di Convalide di processo Gestione dei Change Control Preparazione e gestione Audit clienti Stesura APR Controllo delle Etichette di Spedizione Revisione e Aggiornamento SOP di sito Audit Ministero, Audit clienti QA specialistazienda chimico farmaceuticaIl candidato deve avere: - laurea in materie scientifiche - esperienza minima di 2 anni in ruoli analoghi in ambito QA cleaning validationazienda chimico farmaceuticaOttima opportunità di carriera.

Your Responsibilities: La risorsa, Garantendo il rispetto dei requisiti normativi, di corporate e di site, dovrà: - Collaborare all’introduzione di nuove macchine/sistemi/processi produttivi: o Emettendo il Validation Master Plan o Verificando e approvando la documentazione di convalida relativa (es. Validation Plan/Report, DQ-IQ-OQ-PQ, Component Critical Analysis etc) - Supervisionare le modifiche a macchine/sistemi/processi produttivi gia’ convalidati o Verificando la corretta valutazione dei rischi associati alle modifiche o Verificando e approvando la documentazione di change control (es. risk assessment, reports, SOP etc) - Assicurare e confermare il mantenimento dello s...

Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Multinational Company leader in medical devicesGreat Growth OpportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Degree in Engineering Green Belt Certification will be a plusAt least 2-3 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreath Growth Opportunity

Italy - Monza Job Description: The candidate will support the team leader and his/her team colleagues ensuring the validation of FDA-approved sterile production processes and cleaning activities. S/he will be responsible for writing protocols, executing validation activities and writing validation reports, in compliance with cGMP, Clients’ needs and the Company's quality standards. The Process & Cleaning Validation Specialist will be directly involved in Technology Transfer projects as a subject matter expert and will closely interact with our international clients. We are looking for a highly motivated, result-driven professional, who is willing to take up an all-round role in a...

The Process Engineering Specialist brings operations-expertise to help the organization in order to optimize production processes and realize substantial efficiency and cost saving. Act as a strategic partner, providing value-added solutions, developing and implementing hands-on measures in order to realize the required process improvements and ultimately improve margins; Drive changes and efficiencies by recommending new ways to operate, contributing actively to their actual implementation and providing feedbacks; Build realistic and comprehensive action plans to reduce cost, increase quality and improve service level; Participate at meetings with Automation department in order to define the technical requirement specifications for new equipments considering R&D, QA and Operations requests; Define, execute and validate the production process of new product in collaboration with R&D; Define, write and update production manual (MOP) and guarantee the quality for the entire process; Transfer production process; Execute process changes related to: methods, parameters and material changes; Execute Operational Qualification (OQ) and Performance Qualification (PQ); Execute equipment and production validation using statistical tools such us Gage R&R, Capability analysis, DOE, Regression, Hypothesis tests and others. Promote process improvements using Lean Six Sigma Approach.Medical DevicesGreat growth opportunityGood English level (B1 Level) Management of the validation documents necessary for the process control and improvement and deep knowledge of validation strategy (IQ - OQ - PQ); Knowledge and experience with statistical tools: DOE study, Gage R&R, Capability analysis (Cp, Cpk, Pp, Ppk), sampling size definition preferably by means Minitab sw. Green Belt Certification will be a plus Degree in Engineering At least 4-5 years of experience holding position in process engineering dept.Multinational Company leader in medical devicesGreat growth opportunity