Contributing to site validation planning by preparing and maintaining validation master plans.
Preparing cleaning evaluations for new products or newly introduced equipment.
Performing product trace calculations, conducting risk assessments based on collected data, and executing cleaning validations in line with validated documentation.
Preparing and reviewing cleaning validation protocols & reports, as well as ongoing process and cleaning verification documentation.
Supporting execution of validation activities directly on the shop floor.
Participating in the review of Master Batch Records and related change controls.
Ensuring all assigned activities and projects are maintained in an inspection‑ready state.
Managing deviations related to cleaning/sterilization validation and recommending solutions for resolution and prevention of reoccurrence.
What you may bring to the role:
MSc in Chemistry, Pharmacy, Chemical Engineering, Biotechnology or Pharmaceutical Technology.
Functional knowledge of English.
Proficiency with Microsoft Office tools.
Location: Slovenia (Ljubljana)
We encourage you to submit your profile in English if you would like to be considered for future opportunities in this area.
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.
The future is ours to shape!
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.
Sodelovanje pri podpori načrtovanja validacije na lokaciji z izdelavo in vzdrževanjem glavnih (master) načrtov.
Priprava ocen čiščenja za nove izdelke, ki prihajajo v proizvodnjo, ali ob uvedbi nove opreme.
Izračuni sledov izdelkov, priprava ocen tveganja na podlagi izračunanih in zbranih podatkov ter izvedba validacij čiščenja na podlagi pripravljene dokumentacije.
Sodelovanje pri pripravi / priprava protokolov in poročil za validacijo čiščenja, tekoče preverjanje procesov in čiščenja.
Podpora pri izvajanju validacijskih aktivnosti v proizvodnih prostorih.
Sodelovanje pri pregledovanju glavnih proizvodnih dokumentov (Master Batch Records) in povezanih kontrol sprememb.
Zagotavljanje, da so vse aktivnosti in projekti pod lastno odgovornostjo v statusu pripravljenosti na inšpekcijske preglede.
Upravljanje odstopanj, povezanih z validacijo čiščenja/sterilizacije, ter podajanje priporočil za njihovo učinkovito reševanje in preprečevanje ponovitev.
Vaš doprinos k delovnem mestu:
Univerzitetna diploma kemijske ali farmacevtske smeri, kemijskega inženiringa ali farmacevtske tehnologije.
Aktivno znanje angleškega jezika
Poznavanje orodja Microsoft Office
Lokacija dela: Slovenija (Ljubljana)
Če vas zanima sodelovanje ob naslednjih odprtih priložnostih, vas vabimo, da oddate svojo prijavo v angleškem jeziku.
Kaj nudimo:
Benefits
Flexible schedulePerformance bonus
Additional Information
Job Description Summary
The future is ours to shape!
Job Description
We are continuously looking to connect with talented professionals interested in future opportunities as Validation Expert at our site in Slovenia (Ljubljana). In this role, you may support a manufacturing environment producing both small‑molecule medicines and complex biosimilar pharmaceuticals. Validation Experts play an essential part in ensuring our aseptic production processes meet the highest industry standards.
Sandoz · Ljubljana (sandoz)