Industrial QA & Compliance Specialist

DiaSorin S.p.A.; Piemonte; On-site; EUR 32,000 - 39,000; Full time

Benefits offered by this job

Free canteen

Well-being program

Supplementary pension fund

Supplementary healthcare coverage

Company welfare plan

Job summary

DiaSorin S.p.A. is seeking a QA industrial compliance specialist to ensure Quality Management System application and maintain regulatory alignment across labeling, IFU, and documentation.

Based in Italy, you will draft SOPs, assess risks, and support change control in a fast-paced medical diagnostics environment. Ideal candidates have 2+ years in Medical Device/IVD, strong GMP knowledge, and excellent communication.

Qualifications

• Degree in scientific disciplines such as Chemistry, Pharmacy, Biology, or related fields.
• At least 2 years of Medical Device-IVD or chemical-pharmaceutical industry experience in similar position.
• Knowledge of quality and compliance management as well as GMP requirements and, as plus, requirements applicable to In Vitro Diagnostic Medical Devices.
• Knowledge of the main current requirements applicable to IVD field. Use of Office pack. Risk management and related tools.
• Strong verbal and written communication skills
• Solid problem solving and analytical skills
• Strong communication and interpersonal skills with ability to work well in a high pressure environment
• Strong competency in Customer Focus and Driving for Results
• Native Italian and fluent English

Responsibilities

• to verify the application of the Quality Management System
• to draft and review of standard operative procedures
• to elevate to the line manager risks associated to his/her activities that could impact the QMS
• to verify that procedures are properly established and applied to prevent non-conformity
• to collaborate with the technical teams in the definition of the correct risk assessment on the product/processes
• to support industrial departments in the process of requesting and applying the relevant Change
• to evaluate the impact of the proposed Changes on its own field of competence
• to manage the documentation to release the manufactured lots
• to perform internal and external audits (in presence of appropriate certification)
• to collaborate during audits conducted by external bodies to manage properly the teamto support the correct process of review and release of labeling documents
• to support the correct process of review and release of quality system documentation
• to define actions for continuous improvement

Skills

Verbal communication

Written communication

Analytical skills

Interpersonal skills

Quality compliance

GMP knowledge

Italian native

English fluent

Risk management

Office tools

Education

Scientific degree (Chemistry/Pharmacy/Biology)

Experience in Medical Device/IVD or pharma

Knowledge of GMP

Knowledge of IVD requirements

Office suite proficiency

Tools

MS Office

Job description

DiaSorin S.p.A. is seeking a QA industrial compliance specialist to ensure Quality Management System application and maintain regulatory alignment across labeling, IFU, and documentation.

Based in Italy, you will draft SOPs, assess risks, and support change control in a fast-paced medical diagnostics environment. Ideal candidates have 2+ years in Medical Device/IVD, strong GMP knowledge, and excellent communication.