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

4 settimane fa

Pisa PI, Italia AOP Health A tempo pieno

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Italy we are looking for a: 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. 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. Main Benefits - Bonus - Homeoffice - Company car - Employee mobile phone - Flexible working hours - Laptop - Initial and continuing education - Canteen - Good transport connection - Employee events - Meal allowance - Company doctor - Parking spot - Healthmeasures - Employee discount Your Contact Kathrin Breuer, BA, MA Senior Associate Talent Aquisition Further information on our website: #J-18808-Ljbffr

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