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Quality & compliance specialist (limited 1 year) (italy)

Pisa
AOP Health
Pubblicato il 30 ottobre
Descrizione

PpAOP 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: /p pbIn 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. /b /p pbThis position is limited to a minimum of one year as maternity leave cover. /b /p h3What Your Day To Day Will Look Like /h3 ul liSupport the Quality Management System (QMS/eQMS) in compliance with GxP and corporate procedures. /li liDraft, update, and maintain quality documentation and SOPs. /li liProvide training (onboarding and recurring) on quality and compliance processes. /li liManage incidents, complaints, CAPAs, deviations, and returns. /li liEnsure compliance in daily operations, including documentation and archiving (paper and digital). /li liConduct supplier and customer qualification. /li liCoordinate internal and external audits, including follow-up and CAPA plans. /li liMonitor compliance with GDP, GVP, GDocP, Legislative Decree 219/2006, AIFA, EMA, and other regulations. /li liSupport corporate compliance policies (anti-bribery, transparency, HCP interactions, scientific information, drug traceability). /li liHandle transparency reporting (Sunshine Act) and approval workflows for promotional materials, events, donations, and sponsorships. /li /ul h3Qualifications and Experience /h3 ul liDegree in Pharmaceutical Chemistry and Technology, Pharmacy, Biology, or related field. /li liMinimum of 3 years of professional experience in Quality Assurance or Compliance in the pharmaceutical or healthcare sector. /li liSolid knowledge of GxP standards (GDP, GVP, GDocP) and understanding of EU/Italian regulatory frameworks (AIFA, EMA, Legislative Decree 219/2006). /li liHands‑on experience with Quality Management Systems (QMS/eQMS) and document control processes. /li liProven ability to manage audits, CAPAs, deviations, and complaints. /li liStrong communication and organizational skills with the ability to work independently. /li liFluency in English and Italian (spoken and written). /li /ul h3Our Offer /h3 ul liAn open corporate culture with the opportunity to contribute your own ideas. /li liStructured onboarding and training opportunities to support your professional growth. /li liBeing part of a successful team who drives the business forward. /li liCompetitive bonus scheme, additional benefits and employee events. /li liOpportunities for personal and professional development within an international environment. /li liA role with high impact and responsibility in a growing, innovative company. /li /ul h3Main Benefits /h3 ul liBonus /li liHomeoffice /li liCompany car /li liEmployee mobile phone /li liFlexible working hours /li liLaptop /li liInitial and continuing education /li liCanteen /li liGood transport connection /li liEmployee events /li liMeal allowance /liliCompany doctor /li liParking spot /li liHealthmeasures /li liEmployee discount /li /ul h3Your Contact /h3 pKathrin Breuer, BA, MA /p pSenior Associate Talent Aquisition /p pFurther information on our website: /p /p #J-18808-Ljbffr

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