Quality Assurance & Compliance Specialist, IVD/GMP

Diasorin; Saluggia; On-site; EUR 32,000 - 39,000; Full time

Benefits offered by this job

Permanent contract

CCNL classification (Italian CCNL)

Base salary 35,117.32€

Variable compensation

Free canteen

Well-being program

Pension fund

Supplementary healthcare

Job summary

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions. The Diagnostics Specialist role sits within the Quality Assurance function to ensure industrial activities meet internal and external requirements, with responsibilities spanning QMS verification, SOP drafting, risk assessment, and support for change management.

The position requires a degree in scientific disciplines and at least 2 years in the Medical Device-IVD or chemical-pharmaceutical industry, plus strong

Qualifications

• Degree in scientific disciplines such as Chemistry, Pharmacy, Biology or related field.
• At least 2 years of Medical Device-IVD or chemical-pharmaceutical industry experience in similar positions.
• Knowledge of quality and compliance management, GMP requirements, and IVD-related regulatory expectations.
• Strong verbal and written communication skills and analytical thinking.
• Ability to work under pressure with excellent customer focus and drive for results.
• Native Italian and fluent English.

Responsibilities

• Verify the application of the Quality Management System.
• Draft and review standard operating procedures.
• Elevate risks to line manager related to activities impacting the QMS.
• Verify that procedures are established and applied to prevent non-conformity.
• Collaborate with technical teams on risk assessment for products and processes.
• Support industrial departments in change requests and assess impacts.
• Manage documentation to release manufactured lots.
• Perform internal and external audits; support audits by external bodies.
• Support review and release of labeling documents and quality system documentation.
• Define actions for continuous improvement.

Skills

Quality assurance

GMP knowledge

IVD industry experience

Verbal and written communication

Problem solving

Customer focus

Driving for results

Italian native

English fluent

Education

Degree in Chemistry/Pharmacy/Biology

Professional qualification in related field

Job description

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions. The Diagnostics Specialist role sits within the Quality Assurance function to ensure industrial activities meet internal and external requirements, with responsibilities spanning QMS verification, SOP drafting, risk assessment, and support for change management.

The position requires a degree in scientific disciplines and at least 2 years in the Medical Device-IVD or chemical-pharmaceutical industry, plus strong