Adecco Italia Spa for an important pharmaceutical company, is looking for a
QUALITY ASSURANCE SPECIALIST
In compliance with GxP, applicable regulations and company policies, he/she ensures adequate control of the distribution chain of medicinal products and medical devices, maintain quality system compliance and ensure relevant requirements are met.
Reporting to the country Quality Assurance Lead, he/she will be responsible for the following tasks:
* Management of QMS and monitoring its effectiveness
* Deviation, investigation, CAPA, change control management, MAH assessment, risk analysis, follow-up and tracking
* Document control and update of quality documents
* Drafting and review of Standard Operating procedures
* Ensure quality and accuracy of documentation and records retention by complying with Good Documentation Practices
* Return management
* Batch disposition
* GxP training program management and execution
* Use of company IT tools for the management and archiving of different types of documentation
* Reporting and data analysis
Skills and competences:
* 2 or more years of experience in similar roles
* Good knowledge of GDP e GMP and medical device applicable regulations
* Fluency in English
* Good Communicator
* Ethics and Integrity
* Results driven
* Foster Collaboration
* Master degree in Chemistry, Pharmacy, Engineering, Biology, Pharmaceutical Chemistry
We offer a fixed term contract for 12 months. Hybrid Work. Duty station Rome.
Titolo di studio:
Laurea Magistrale - Chimico / Biologico / Ambientale - Chimica e tecnologia farmaceutiche
Laurea Magistrale - Medico / Infermieristico - Farmacia
Lingue conosciute:
Inglese: Comprensione Ottimo
Competenze:
Word Processor - Elaborazione testi - Word, livello Ottimo
Fogli di calcolo / elettronici - Excel, livello Ottimo
Farmaco-Scientifico - Farmaceutica, livello Ottimo
Disponibilità oraria: Full Time
Patente: B #J-18808-Ljbffr