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
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