Corporate Quality Assurance Documentation Associate

DiaSorin Group Standard Job Description

Job
Corporate Quality Assurance Documentation Associate

Title

Job

**Organizational Area**: Corporate
Kind of contract

Facts

**Country / State**: Italy
- Full Time / Part Time: Full time

**Place of work**: Saluggia (VC)
- Permanent / Temporary: Permanent

**Home / Office based**: Hybrid work

**Legal Entity**: DiaSorin S.p.A

**Job ID (1)**:
**Professional Family**: Quality Assurance

**Reporting To**: Senior Corporate Quality Assurance Documentation Specialist

Job
YOUR MISSION

Scope
Responsible for ensuring the proper management of Corporate quality system documentation

Main
YOUR CONTRIBUTIONS

**Responsibilities**:

- Handle Corporate quality system documentation and the related Corporate Change Plans till documentation completion and implementation
- keep all the documentation updated and available
- Prepare the documents with the support of the pertinent involved Company functions, as necessary and submit them for approval
- Provide support as needed including procedure creation, tracking of documents or other activities
- Ensure compliance with the Code of Ethics, the Quality Management System, the Company Policies and the Corporate Procedures.

YOU

**Qualifications**:
**Education**: University degree or a professional qualification of an equivalent or higher standard, preferably scientific and technical.

Experience

**Experience**:

- Minimum of 2 -3 years’ experience in the health care and sciences industry, preferably with diagnostic, medical devices or pharmaceutical prior knowledge/experiences.
- Good knowledge of quality assurance within a regulated environment.

**Technical Competencies**: Computer skills:, Google Apps, Excel, Word, PowerPoint, Outlook, Teams

Personal Strengths

**Skills**:

- Personal characteristics : integrity, ethics, confidentiality, sincerity, diplomacy, open-mind, sense of observation, perspicacious, persevering, resolute, self-confident.
- Abilities : analytical skills, ability to work equally as well on your own as in a team, aptitude to good interpersonal relationships, be organized, precise and flexible, optimal written and verbal communication skills. Pursue tasks with energy, drive, and initiative; even in a fast-paced environment

**Languages**: Good spoken and written English.

Mobility

**Travel availability**: na

**Relocation availability**: na

**Training required**:
**Internal training courses in relation to**:

- Good manufacturing Practice
- specific IVD MD processes (e.g. Reagents Manufacturing, Instrument development and Changes, Service and Marketing activities)

**Specific Internal or external training course relation to**:

- Documentation management
- Quality System Requirements (FDA CFR QSR 820, ISO 9001:2015, EN ISO 13485:2016/A11:2021
- Usability requirements,

(1) Assigned by Corporate Human Resources by Country.