Fortil è un gruppo internazionale di consulenza in ingegneria e tecnologia basato su un modello indipendente, che riunisce oltre 2.500 dipendenti. Con 30 sedi in 14 Paesi, Fortil promuove la libertà imprenditoriale e la valorizzazione del potenziale individuale. Siamo alla ricerca di un/una Auditor GxP da inserire all’interno di un contesto strutturato e altamente qualificato, per supportare attività in ambito Affari Regolatori ed di audit Pharmacovigilanza e Good Clinical Practice (GCP). Responsabilità principali: - Pianificazione ed esecuzione di audit (fornitori, CRO, partner, siti clinici) - Audit di sistemi e processi di Pharmacovigilanza (ICSR, signal management, PSMF, QMS) - Verifica di conformità Regolatoria alle normative vigenti (EMA, AIFA, ICH, FDA, ove applicabile) - Audit GCP su studi clinici e processi correlati - Redazione di report di audit, gestione delle azioni correttive e preventive (CAPA) - Collaborazione con Quality Assurance, Clinical Operations e Regulatory Affairs Requisiti richiesti: - Laurea in discipline scientifiche (CTF, Farmacia, Biologia, Chimica, Medicina o affini) - Esperienza pregressa in attività Regolatorie e/o Audit nei seguenti ambiti: - Pharmacovigilanza - GCP / Studi Clinici - Ottima conoscenza delle normative GxP e dei principali riferimenti normativi europei e internazionali - Capacità di analisi, attenzione al dettaglio e approccio orientato alla qualità - Buone capacità comunicative e di gestione degli stakeholder - Ottima conoscenza della lingua inglese (scritta e parlata) - Certificazioni in ambito Audit/GxP e riconoscimento come QP Pharmacovigilance - Esperienza in audit di terze parti (CRO, vendor, outsourcing) - Esperienza in contesti internazionali o multinazionali 📍 Sede di lavoro: remoto 📄 Tipologia contrattuale: collaborazione Perchè unirsi a noi? In Fortil mettiamo in atto iniziative concrete per sostenere il tuo sviluppo e garantire un ambiente di lavoro stimolante: Supporto personalizzato per favorire la crescita delle tue competenze Un ecosistema che incoraggia ad andare oltre la tua zona di comfort L’opportunità di diventare azionista Coinvolgimento in progetti comunitari e non profit Una politica dedicata al sostegno della genitorialità Fortil è impegnata a garantire pari opportunità. Tutte le nostre posizioni sono aperte a persone con disabilità, indipendentemente da genere, origine o orientamento sessuale.

Role Description As a Paediatric Nurse at Komplex Care, you’ll be providing care and support to a client, whose individual needs includes: - Complex Respiratory Needs - PEG - Epilepsy - Personal Care - Medication Administration What You’ll Be Doing: - Delivering personal, practical, social and emotional care to clients with complex needs in their own homes - Designing, delivering and reviewing tailored care plans for each individual - Providing ongoing clinical assessments and support for clients' physical and psychological needs - Leading and supervising care staff, ensuring high standards of clinical practice and compliance - Coordinating and communicating effectively with the MDT, families, and external stakeholders - Delivering specialist clinical training to staff and carers within care packages - Attending and contributing to clinical governance and management meetings at Head Office - Promoting and upholding the values of dignity, respect, and independence in every interaction Qualifications - Registered Nurse (NMC) with up-to-date PIN - Experience in complex care, specifically respiratory (training provided) - Strong leadership, mentoring, and clinical teaching skills - Excellent communication and interpersonal abilities - Understanding of safeguarding, risk assessment, and care planning - IT literacy (Microsoft Office & care database systems) - A full UK driving licence and willingness to travel Requirements - Mentoring qualification (desirable) - Experience in community nursing or working with MDTs (desirable) - Familiarity with clinical governance frameworks and audit processes (desirable) Benefits - Pension Scheme for long-term security - 24/7 GP access for you, your partner, and children (up to 18) - Free mental health support for you, your partner, and children (up to 18) - Life insurance for peace of mind when it matters most - Home life advice line for everyday guidance - Career development opportunities - Wellbeing videos and guided meditations - Earn points for staying active - Vouchers for Amazon, Tesco, Nike and more - Up to 33% off gym memberships - Employee of the Month recognition with a £50 voucher Company Description Komplex Care stands at the forefront of national care provision, delivering high-quality, nurse-led, person-centred care in the comfort of our clients' homes. We specialise in supporting both adults and children with complex conditions ranging from but not limited to spinal injuries, brain injuries & behaviour that may challenge. We strive to provide tailored complex care with a personal touch. Our mission is simple: to empower individuals to lead fulfilling, independent, and dignified lives. Every client receives dedicated attention from their own Operations Manager and Registered Nurse, ensuring continuity, compassion, and the highest standards of care in their preferred environment. We are equally committed to our team, offering meaningful training, continuous support, and genuine opportunities for career development.

• Provide a broad range of fully integrated audit services for our global clients • Provides timely, high-quality deliverables covering complex sections, with a reasonable number of workpaper comments • May facilitate fieldwork, coordinate deliverables from multiple team members • Demonstrates depth of knowledge of methodology, relevant standards, and systems and may collaborate with Manager to guide associates, interns and monitor productivity and workplan schedule • Proactively addresses client concerns and escalates issues as they arise • Interacts with clients and engagement teams to help ensure the information flow from the client to the team is efficient

Primary Location: Work From Home - KY - UMC Address: Home Office Remote, KY 40601 Shift: Job Description Summary: UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and Brown Cancer Center. With more than 12,000 team members—physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals—UofL Health is focused on one mission: delivering patient-centered care to each and every patient each and every day. Job Description: This employee conducts monitoring, analysis, routine audits, investigations and special projects associated with the 340B Drug Pricing Program in compliance with State and Federal regulations (enabling health care organizations that care for underserved people to purchase outpatient drugs at discounted prices). The analyst assists with development of monitoring protocols and efficient and effective internal controls for the 340B Drug Program. Essential Functions: Executes and documents self-audit activities of the 340B Drug Program - Conducts routine/periodic audits to identify issues and areas of improvement - Obtains, analyzes, and appraises data to identify and evaluate the system of control in the 340B Drug Program - Identifies opportunities for improvement, analyzes WAC spend, researches causes, and formulates recommendations - Reviews pharmacy purchase orders to ensure compliance and optimization of procurement under the program - Maintains and tests critical tracking software and documentation of key policies and procedures - Reflects system database changes within drug formulary or product specifications - Performs work outlined in analysis plan as directed by 340B Program Manager Ensures 340B Rules/Guidance Surveillance - In coordination with 340B Program Manager, monitors and assess 340B guidance and/or rule changes - Participates in conferences and/or webinars pertinent to the 340B Drug Program - Attends education/training events (internal and external) - Reviews 340B program policies and procedures on an ongoing basis and offer contributions and changes to ensure 340B compliance - Ensures split-billing software integrity and reviews applicable reports for areas of improvement Other Functions: - Adheres to all Hospital policies and procedures, as well as federal and state regulations. - Advanced knowledge of the 340B Drug Program compliance program requirements and its interdependencies with within the covered entity and contract pharmacies - Review 340B program policies and procedures on an ongoing basis and offer contributions and changes to ensure 340B compliance - Completes and maintains required documentation for compliance with 340B program. - Achieves and maintains a satisfactory working relationship with Pharmacy Leadership, Pharmacy Staff, and other departments throughout the system - Maintains compliance with all company policies, procedures and standards of conduct - Complies with HIPAA privacy and security requirements to maintain confidentiality at all times - Performs other duties as assigned Additional Job Description: Education: - Bachelor’s Degree in business, accounting, finance, or healthcare related area (required) Experience: - Two (2) years of pharmacy technician experience with one (1) year working in 340B compliance, pharmacy administration, or pharmacy purchasing (required) Licensure: - Registered as a Pharmacy Technician with the State Board of Pharmacy Examiners Certification: - 340B Apexus Certified Expert (ACE) certification completed within 1 (one) year of hire - Current National Board certification by Pharmacy Technician Certification Board® or National Healthcareer Association (preferred)