Quality & Compliance Specialist (Limited 1 Year) (Italy)

1 settimana fa

Pisa, 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 LikeSupport 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 ********, 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 ExperienceDegree 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 ********).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 OfferAn 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 BenefitsBonusHomeofficeCompany carEmployee mobile phoneFlexible working hoursLaptopInitial and continuing educationCanteenGood transport connectionEmployee eventsMeal allowanceCompany doctorParking spotHealthmeasuresEmployee discountYour ContactKathrin Breuer, BA, MASenior Associate Talent AquisitionFurther information on our website:#J-*****-Ljbffr

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