Product Steward III

1 week ago


Ljubljana, Ljubljana, Slovenia Lek, a Sandoz company Full time €40,000 per year

Job Description
Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

As
Product steward III
you will be responsible for including content knowledge of products throughout their life cycle.

Join us as a Founder of our 'new' Sandoz and Lek

Your Key Responsibilities

  • Maintaining control over the production process of selected products throughout their entire life cycle, from development transfer to the present moment, and sustaining appropriate knowledge.
  • Supporting root cause analysis of process failures and participating in product improvement projects as agreed.
  • Evaluating the impact of technical changes, assessing their technical feasibility, determining the scope of technical batches, and verifying the technical risks and business benefits of proposed technical changes.
  • Taking care of the preparation of the electronic technological procedure (MBR).
  • Responsibility for ensuring continued validation (process validation, continuous validation, etc.) for selected products.
  • Approving validation protocols and reports on technical changes.
  • Providing necessary data for technical activities during product launch or transfer, focusing on existing knowledge with appropriate documentation and, if necessary, supporting the receiving site.
  • Participating in projects to enhance the robustness and sustainability of products.

What You Will Bring To The Role

  • University degree in pharmacy, pharmaceutical technology, chemistry, or other relevant scientific fields. A master's degree in the mentioned fields is desirable.
  • Proficiency in English.
  • Knowledge of Microsoft Office tools.
  • No work experience required.

You'll Receive
Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.

Possible job locations:
Slovenia
(Ljubljana)

We offer
temporary contract
(one year, with the possibility of extension) with 6-month of probation period. You are kindly invited to submit your application in English or Slovene language, including CV.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

Commitment To Diversity & Inclusion
Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

Sandoz

___________________________________

Kot Product Steward III boste odgovorni za vsebinsko poznavanje izdelkov skozi celoten življenjski cikel.

Pridružite se nam kot soustanovitelj 'novega' Sandoza in Leka

Vaše Ključne Odgovornosti

  • Ohranitev nadzora nad proizvodnim procesom izbranih izdelkov skozi celoten življenjski cikel – od prenosa razvoja do danes – ter ohranjanje ustreznega znanja.
  • Podpora pri analizi osnovnega vzroka napak v procesu in sodelovanje pri projektih izboljšav izdelkov po dogovoru.
  • Vrednotenje vpliva tehničnih sprememb, ocenjevanje tehnične izvedljivosti, določanje obsega tehničnih serij ter preverjanje tehničnih tveganj in poslovnih koristi predlaganih sprememb.
  • Skrb za pripravo elektronskega tehnološkega postopka (MBR).
  • Odgovornost za zagotavljanje stalne validacije (validacija procesa, kontinuirana validacija itd.) za izbrane izdelke.
  • Potrjevanje validacijskih protokolov in poročil o tehničnih spremembah.
  • Zagotavljanje potrebnih podatkov za tehnične aktivnosti ob lansiranju ali prenosu izdelka, s poudarkom na obstoječem znanju in ustrezni dokumentaciji ter po potrebi podpora prejemnemu mestu.
  • Sodelovanje v projektih za izboljšanje robustnosti in trajnosti izdelkov.

Kakšni So Pogoji In Vaš Doprinos

  • Univerzitetna izobrazba iz farmacije, farmacevtske tehnologije, kemije ali drugih ustreznih znanstvenih področij. Zaželena je magisterska izobrazba na omenjenih področjih.
  • Znanje angleškega jezika.
  • Poznavanje orodij Microsoft Office.
  • Delovne izkušnje niso zahtevane.

Možne lokacije dela:
Slovenija
(Ljubljana)

Z izbranim kandidatom bomo sklenili delovno razmerje za
določen čas.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate preko spletne povezave.

Zakaj Sandoz in Lek?
Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več

Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil.

Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke. V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero.

Prihodnost je v naših rokah

Predani Smo Raznolikosti In Vključenosti
Sandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.

Sandoz

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