Ekspert upravljanja kakovosti ESO FDF I

Job Description Summary

#LI-Hybrid
Lokacija / Location: Ljubljana

Kot Ekspert upravljanja kakovosti zunanjih dobaviteljev (m/ž/d) se pridružite dinamični skupini ekspertov v oddelku za obvladovanje zunanjih dobaviteljev, kjer z nadzorom nad procesi, proizvodnjo, analitiko in sistemom kakovosti, potrjujemo usteznost zunanjih dobaviteljev končnih farmacevtskih izdelkov za Novartis. Skupina podpira več kot 50 različnih Novartisovih inovativnih izdelkov, ki jih Novartis dobavlja pacientom po celem svetu.

As a Quality Assurance Manager for external suppliers, you will join a dynamic group of experts in the External Supplier Management Department, where we confirm the suitability of external suppliers of final pharmaceutical products for Novartis by controlling processes, production, analytics and the quality system. The Group supports more than 50 different Novartis innovative products that Novartis supplies to patients around the world.

This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Job Description

Vaše ključne odgovornosti:

• Kontaktna oseba za vse aktivnosti pri zunanjih dobaviteljih, povezanih s kakovostjo.
• Odgovornost za izdelavo ocen tveganja zunanjih dobaviteljev.
• Skrb, da je na voljo veljavna pogodba o zagotavljanju kakovosti, skladna z zahtevami globalne predloge, ki jasno opredeljuje vloge in odgovornosti cGMP med Novartisom in zunanjim dobaviteljem, ter podrobne podatke in zahteve o izdelku. 
• Obravnavanje kritičnih problemov glede kakovosti (odstope, reklamacije, odpoklice, ponaredbe in nedovoljeno poseganje v izdelke, neustrezni rezultati stabilnosti itd.) v skladu s pogodbo o kakovosti in Poslovnikom kakovosti v Novartisu. Skrbi za pravilno izvedbo raziskav.
• Sodelovanje pri pripravi predlogov za spremembe, bodisi zunanjega dobavitelja ali Novartisa, ter skrb za to, da se obravnavajo v skladu s pogodbo o kakovosti in splošnimi postopki Novartisa od prevzema do izvedbe in zaključka. 
• Sodelujovanje z drugimi funkcijami v Novartisu, ki tudi obvladujejo zunanje dobavitelje, in sicer z nabavo, pravno službo, oskrbo, regulatornim CMC, registracijami zdravil, itd.
• Odgovornost za osebni in strokovni razvoj.
• Izvajanje in upoštevanje vseh navodil in zahtev za zagotavljanje varnega dela, varovanja okolja in premoženja.
• Ostale naloge določene z letnim pogovorom o ciljih in s kazalniki uspešnosti.
• Druge naloge po navodilu nadrejenega in naloge na podlagi posebnega imenovanja.

Vaš doprinos k delovnem mestu:

• Visokošolska izobrazba farmacevtske, kemijske ali druge primerne smeri.
• Tekoče znanje angleškega jezika.
• Poznavanje orodja MS Office.
• Pet let delovnih izkušenj s področja upravljanja kakovosti, kontrole kakovosti, proizvodnje, regulative ali drugega primernega strokovnega področja.

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom lahko oddate preko spletne povezave.

Ugodnosti in nagrajevanje: Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, možnost vključitve v kolektivno zdravstveno zavarovanje, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja).), številne priložnosti za učenje in razvoj.

Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj:  

Predani smo raznolikosti in vključenosti: Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

Zakaj Novartis: Pomagati bolnikom in njihovim družinam zahteva več kot le inovativno znanost. Potrebna je skupnost zavzetih ljudi, kot ste vi. V Novartisu cenimo sodelovanje, podporo in navdihovanje drug drugega za razvoj prebojnih terapij, ki spreminjajo življenja pacientov. Ste pripravljeni ustvariti svetlejšo prihodnost skupaj z nami?  

Pridružite se Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo:  

Key Responsibilities:

• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier.
• Responsible for producing risk assessments of external suppliers.
• Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements.
• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual.   Ensure investigations are correctly executed.
• Cooperate at the preparation of change requests, either from the External Supplier or from Novartis, and ensures they are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.
• Collaborates with other functions at Novartis that also control external suppliers, namely purchasing, legal, procurement, regulatory CMC, drug registrations, etc.
• Responsibility for personal and professional development.
• Providing conditions for and control of the implementation of HSE tasks and requirements in the unit.
• Other tasks determined during the annual objectives setting process and by KPIs.
• Other tasks as assigned by the supervisor, and tasks based on a specific appointment.     

Essential Requirements:

• University degree in pharmaceutical, chemical or other appropriate sciences.
• Fluent in English.
• Knowledge of Microsoft Office.
• Five years of work experience in the field of quality management, quality control, production, regulation or another appropriate professional field.

We offer a temporary employment with 6 month of probation period .  

You are kindly invited to submit your application.

Benefits and Rewards: Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), Unlimited learning and development opportunities.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

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