Qa & Csv Officer

The purpose of this role is to ensure that computer systems are properly validated and maintained in a compliance status, through appropriate change control management and periodic review.
Principal Accountabilities
- To develop validation strategies and to manage GxP system lifecycle documentation, including planning, requirements and system design documents, Testing Protocols, System release documents and maintenance documents (e.g.
Change Control, Periodic Review, Incident management, etc ) in accordance to GAMP5 and internal SOPs.
- Ensures compliance of managed computerized systems to relevant regulatory requirements (e.g.
cGMP/GCP/GAMP, Data Integrity) ensuring the completeness and consistency of systems life cycle documentation
- Ensures project team complies with the CSV methodology
- To conduct System Compliance Determination
- To cooperate in the definition of the GxP System Risk Assessment liaising with Senior CSV Specialist, project and system stakeholders
- To oversee system change requests and associated documentation
- To oversee GxP document storage and to manage documentation logs
- Cooperates with the technical team in the investigations into systems and validation incidents in order to define and implement appropriate resolutions.
Reviews proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system's validation status
- To support the Senior CSV Specialist in Client audit and regulatory inspections
- To conduct CSV training to Arithmos' personnel
- To collaborate in the definition of CSV SOPs, WIs, guidelines and best practices.
Professional Background and Experience
Bachelor Degree in Computer Science, Engineering or Scientific Area and at least 1 year of experience as CSV specialist in Pharma industry
Technical Competencies
Knowledge of CSV regulations and guidelines (21CFR part 11, Annex 11, GAMP5, Data Integrity)
Knowledge of pharma processes and GxP regulations (mainly GCP, GVP, cGMP) Knowledge of risk management principles
Base Knowledge of applicable ISO/IEC Legislation
Base Knowledge of computer information requirements legislation (privacy regulations)
English, Fluent
Behavioural Competencies
Collaboration & Cooperation
Flexibility
Initiative
Communication
Quality Orientation
Teamwork
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Benefit:
- Buoni pasto
- Cellulare aziendale
- Computer aziendale
- Fondo pensione
- Formazione professionale
- Lavoro da casa
Disponibilità:
- Dal lunedì al venerdì
Retribuzione supplementare:
- Bonus
Considerazioni sul COVID-19:
SI