Quality Assurance Specialist

Euren Intersearch; Milano; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A biopharmaceutical company is seeking a Quality Assurance Specialist in Milan. You will implement and maintain the International Quality Management System, ensuring compliance with GDP and other international standards. The ideal candidate has 2-5 years in Quality Assurance within the pharma sector and is fluent in English. Join a company dedicated to innovation in oncology with a substantial history in drug development.

Competenze

• Experience supporting external and internal audits.
• Good knowledge of GxP and Quality Management System requirements.

Mansioni

• Writing and reviewing Standard Operating Procedures (SOPs).
• Managing quality events such as deviations and related Corrective and Preventive Actions (CAPAs).
• Managing quality technical complaints from the market.
• Supporting the preparation and execution of internal audits.

Conoscenze

Fluent English (written and spoken)

Team player with the ability to work independently

Proactive and well-organized

Strong analytical skills

Formazione

2-5 years of experience in Quality Assurance in a Pharma Company

Certification as a Quality Management System Auditor

Descrizione del lavoro

Our client is an Italian Biopharmaceutical Company with over a century of history and expertise in the development and commercialization of innovative molecules. We are looking for the

QUALITY ASSURANCE SPECIALIST

About the Company

With a strong history and a commitment to innovation, our client is dedicated to providing innovative drugs in Oncology. As part of an ambitious strategic plan, the Company is expanding its presence and growing in Europe, starting from Italy, which will serve as the Headquarters for the International Operations.

The Opportunity

To enable the Company's growth, we are seeking a talented and experienced Quality Assurance Specialist reporting directly to the International QA Manager, working on the implementation and maintenance of the International Quality Management System fully compliant with GDP and other international guidelines and standards.

Key Responsibilities

1. Writing and reviewing Standard Operating Procedures (SOPs)
2. Managing quality events such as deviations and related Corrective and Preventive Actions (CAPAs)
3. Managing quality technical complaints from the market and change controls
4. Supporting the management of returns and recalls from the market
5. Supporting the preparation and execution of internal audits and related CAPAs follow-up
6. Supporting the preparation and execution of trainings across the countries and the qualification and monitoring of external suppliers' performance

Requisiti

Education and Experience Requirements

• 2-5 years of experience in Quality Assurance in a Pharma Company
• Previous experience supporting the execution of external and internal audits and/or Certification as a Quality Management System Auditor
• Good knowledge of GxP and Quality Management System requirements

Required Skills

• Fluent English (written and spoken)
• Team player with the ability to work independently
• Proactive, well-organized with strong analytical skills, adaptable to changing priorities
• High integrity, confidentiality, and empathy