Site Name: Italy - Parma Posted Date: Dec 19 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Siamo alla ricerca di un talentuoso Process Validation Specialist che si unisca alla nostra dinamica Unità di Product Lifecycle Management (PLM) – Process Validation, situata nell'Area Tecnica. In questo ruolo chiave, riporterai direttamente al PLM – Process Validation Lead e avrai l'opportunità di fare la differenza nel garantire l'eccellenza operativa. In questo ruolo TU.. Gestirai ed effettuerai modifiche (change control) a processi/prodotti convalidati (iniettabili e per uso orale) e ai relativi sistemi associati (componenti primari, materiali a contatto, sistemi monouso, fasi di processo), in allineamento ai principi del PLM, allo scopo di mantenere lo stato di convalidato del sistema; Gestirai ed effettuerai le attività di convalida/riconvalida relative a processi/prodotti definite sulla base degli impatti su TRA (Technical Risk Assessment) e PCS (Product Control Strategy) del prodotto; Gestirai, effettuerai o supporterai la definizione della strategia e l’esecuzione delle attività di convalida di processo per prodotti GSK in termini di business continuity, in allineamento ai principi di Quality By Design e Continued Process Verification (CPV); Garantirai il flusso e la corretta gestione documentale dei processi sopra indicati tramite: Gestione del processo di change control nel sistema infomatico, in qualità di change coordinator o Emissione di Validation Master Plan, Validation Plan, Validation Summary, ecc. Emissione e/o verifica di protocolli e report di PS, OQ, PQ, MQ, ecc.; Dove richiesto, supporterai l’allestimento delle sezioni di convalida di processo/prodotto, dei relativi dossier registrativi per l’introduzione di modifiche su specialità registrate; Perchè TU? Qualifiche e Requisiti richiesti: Laurea in CTF, Biotecnologie, Ingegneria Chimica, Chimica o Farmacia Buona conoscenza della lingua inglese sia scritta che parlata Buona conoscenza delle normative di riferimento (EU GMP Part I, II e III e annexes, CFR 21 Part 11, ICHQ9, Q10, Q11 e Q12, PDA) e in materia di product/process validation (US/EU Guidelines e Regulations) e cleaning validation Conoscenza base di statistica per la valutazione di dati di convalida di processo (Process Capability, Power analysis, Analisi della varianza, Control chart/ Trend plots, guideline ISO di riferimento (ISO-16269-6) Esperienza in materia di cleaning verification e cleaning validation Qualifiche e Requisiti preferibili: Esperienza nella convalida di impianti, equipment, processi di ispezionamento di prodotti liquidi, liofilizzati e solidi orali e metodiche analitiche per NCE e Biopharm Product Competenze di troubleshooting, problem solving, risk management e nell’utilizzo dei tools FMEA, Fish bone ecc. Buona conoscenza delle normative ISO di pertinenza, delle ICHQ3C e D, ICHQ8 e della ICHM7 Capacità comunicative e relazionali (all’interno di team di lavoro multidisciplinari) Capacità organizzative e orientamento all’obiettivo Cosa offriamo: Un ambiente di lavoro stimolante, innovativo e realmente inclusivo. Opportunità di crescita e di sviluppo professionale. Contratto a tempo indeterminato. Pacchetto retributivo competitivo, Performance Reward e Flexible Benefits. Company Healthcare Plan. Fondo pensione integrativo. Employee Assistance programme. Sustainable mobility programme. Mensa aziendale. Closing Date for Applications – January 6th, 2025 Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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