Quality & Compliance Specialist (Italy) (limited 1 year) (f/m/d)

AOP Health; Pisa; In loco; EUR 45.000 - 60.000; Tempo pieno

Descrizione del lavoro

A healthcare company located in Tuscany, Italy is seeking a Quality Assurance professional for a maternity leave cover role. The successful candidate will support compliance with regulatory standards and manage quality documentation. Required qualifications include a degree in Pharmaceutical Chemistry, at least 3 years of experience in Quality Assurance, and proficiency in English and Italian. This position offers a competitive bonus scheme and opportunities for professional development.

Servizi

Competitive bonus scheme

Structured onboarding and training

Opportunities for personal and professional development

Employee events

Competenze

• Minimum of 3 years of professional experience in Quality Assurance or Compliance in the pharmaceutical or healthcare sector.
• Solid knowledge of GxP standards and understanding of EU/Italian regulatory frameworks.
• Hands-on experience with Quality Management Systems and document control.

Mansioni

• Support the Quality Management System in compliance with GxP and corporate procedures.
• Draft, update, and maintain quality documentation and SOPs.
• Coordinate internal and external audits, including follow-up and CAPA plans.

Conoscenze

GxP compliance

Regulatory knowledge

Quality Management Systems

Auditing skills

Communication skills

Organizational skills

Fluency in English

Fluency in Italian

Formazione

Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Biology, or related field

Descrizione del lavoro

In this role, you will ensure compliance with regulatory and corporate requirements while supporting our local Quality Management System. You will work in close collaboration with cross-functional teams to maintain the highest standards of quality and compliance.

This position is limited to a minimum of 1 year as maternity leave cover.

What Your Day To Day Will Look Like

• Support the Quality Management System (QMS/eQMS) in compliance with GxP and corporate procedures.
• Draft, update, and maintain quality documentation and SOPs.
• Provide training (onboarding and recurring) on quality and compliance processes.
• Manage incidents, complaints, CAPAs, deviations, and returns.
• Ensure compliance in daily operations, including documentation and archiving (paper and digital).
• Conduct supplier and customer qualification.
• Coordinate internal and external audits, including follow-up and CAPA plans.
• Monitor compliance with GDP, GVP, GDocP, Legislative Decree 219/2006, AIFA, EMA, and other regulations.
• Support corporate compliance policies (anti-bribery, transparency, HCP interactions, scientific information, drug traceability).
• Handle transparency reporting (Sunshine Act) and approval workflows for promotional materials, events, donations, and sponsorships

Your Qualifications and Experience

• Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Biology, or related field.
• Minimum of 3 years of professional experience in Quality Assurance or Compliance in the pharmaceutical or healthcare sector.
• Solid knowledge of GxP standards (GDP, GVP, GDocP) and understanding of EU/Italian regulatory frameworks (AIFA, EMA, Legislative Decree 219/2006)
• Hands-on experience with Quality Management Systems (QMS/eQMS) and document control processes
• Proven ability to manage audits, CAPAs, deviations, and complaints
• Strong communication and organizational skills with the ability to work independently
• Fluency in English and Italian (spoken and written)

Our Offer

• An open corporate culture with the opportunity to contribute your own ideas
• Structured onboarding and training opportunities to support your professional growth.
• Being part of a successful team who drives the business forward
• Competitive bonus scheme, additional benefits and employee events.
• Opportunities for personal and professional development within an international environment
• A role with high impact and responsibility in a growing, innovative company