Quality & Compliance Specialist (limited 1 year) (Italy)

AOP Orphan; Deutschland; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading healthcare company in Germany is looking for a Quality & Compliance Specialist to ensure compliance with regulatory and corporate requirements. This role involves collaboration with cross-functional teams to support the Quality Management System. Ideal candidates should have a degree in a related field and at least 3 years of experience in Quality Assurance or Compliance. This is a limited position covering maternity leave and offers a competitive bonus scheme.

Leistungen

Structured onboarding and training opportunities

Competitive bonus scheme

Employee events

Qualifikationen

• Minimum of 3 years of professional experience in Quality Assurance or Compliance.
• Solid knowledge of GxP standards (GDP, GVP, GDocP) and EU/Italian regulations.
• Fluency in English and Italian.

Aufgaben

• Ensure compliance with regulatory requirements in daily operations.
• Support Quality Management System (QMS) compliance with GxP and corporate procedures.
• Draft and maintain quality documentation and SOPs.

Kenntnisse

Regulatory compliance

Quality Management Systems (QMS)

Audit management

Communication skills

Organizational skills

Ausbildung

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

Jobbeschreibung

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team inItaly we are looking for a :

Quality & Compliance Specialist (limited 1 year) (Italy)

56122 Pisa Vollzeit Start : as of now

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 one 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 organisational 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.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then :