Quality Document Control Specialist Lazio

Quality Document Control Specialist
Roma
Lazio, Lazio

PURPOSE

The Quality Systems and Document Control Specialist develops, establishes and maintains the BVI quality management

system (QMS) (Quality Management System) ensuring that the quality performance of processes conform to the applicable

regulatory standards to ensure lasting product quality customer satisfaction.

Implements regulations and internal policies to

assure compliance.

Oversees the document control process.

**RESPONSIBILIITES**:

May execute and fulfill the following responsibilities:

- Supports Quality Management System activities within the Company QMS in compliance with BVI policies and

international standards

- Maintains the QMS including implementation of QA team objectives

- Manages the creation, development/review and approval of changes to quality documents, such as procedures,

Work Instructions and Job Aides

- Follow-up on Corrective and Preventative Actions (CAPA) and related tasks

- Implements documentation strategy within the BVI QMS

- Dry-run testing of new work instructions/guidance documents

- Supports internal and external audits

- Conducts quality awareness trainings as required

- Support process owners with implementation of quality requirements for processes within the QMS

- Collecting and coordinating flow of information for regular management reporting, related to the deployment of QMS

content

- Development of QMS related content to be deployed through the eQMS Learning Management System

**Qualifications**:

- Bachelor degree

- Min.

3 years of relevant working experience in a highly regulated international environment (preferably in biomedical

technology)

- Excellent knowledge of spoken and written Italian and English

- Understanding Quality Management Systems and process approach to QMS

- Familiarity with document control process

- Excellent communication and presentation skills

- Ability to work with remote teams and communicate with a wide range of cultures

- Experience in developing processes and documentation, including process diagramming

- Strong attention to detail

- Familiarity with process improvement and change management frameworks

- Analytical skills & pragmatic approach

- Problem solve

Ability to commute/relocate:

- Roma: Reliably commute or planning to relocate before starting work (preferred)

**Experience**:

- Biomedical: 3 years (preferred)