QC Specialist in the bioanalytical laboratory

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 a
(Senior) QC Specialist in the bioanalytical laboratory
, you will play a key role in its establishment, the design of laboratory processes, and the implementation of analytical methods. This is an exceptional opportunity to actively contribute to laying the foundation for the successful operation of the laboratory. As part of a dynamic and interdisciplinary team, you will gain valuable professional expertise and contribute to ensuring compliance with regulatory requirements and the high quality of bioanalytical tests that support commercial products.

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

Your Key Responsibilities
Your responsibilities include, but not limited to:

• Active involvement in the handling of deviations (e.g. out-of-specification results – OOX) and leading and implementing corrective and preventive actions (CAPA).
• Support in the transfer of analytical methods: preparation of documentation, training of colleagues, and transfer of expert knowledge.
• Review and approval of analyses in accordance with GMP for analytical release purposes.
• Participation in internal and external inspections.
• Preparation and revision of documentation (Standard Operating Procedures – SOP, Work Instructions – WP, equipment qualification, and others).
• Good understanding of biological tests and the ELISA (Enzyme-Linked Immunosorbent Assay) method.
• Support to colleagues in daily tasks and resolving technical challenges.
• Active role in organizing and establishing an efficient bioanalytical laboratory.

What You Will Bring To The Role

• Completed at least Master's level degree in a natural science field – biology, biochemistry, biotechnology, microbiology, laboratory biomedicine, or a related discipline.
• At least two years of experience in a GMP environment (for a senior position, at least five years of relevant experience). Candidates with experience in the pharmaceutical industry and in the quality control department are preferred. Knowledge and practical experience with cell culture work is desirable.
• Proficient in English (written and spoken).
• Computer literacy.
• High level of accuracy, responsibility, and ability to work in a team; well-developed communication skills; ability to make independent decisions and solve problems efficiently; adaptability, proactivity, and willingness to engage in continuous learning.

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
(Lendava)

We offer
permanent contract with 6-month of probation period
. You are kindly invited to submit your application in English language, including CV, by

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. 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

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.

______________________________________________________________________________________________________

Sandoz, katerega del je tudi Lek, je trenutno kot pionir in vodilni svetovni ponudnik trajnostnih generičnih in podobnih bioloških zdravil v vznemirljivem in preobrazbenem obdobju.

Kot samostojno podjetje, ki kotira na borzi, Sandoz zdaj stremi k še večji strateški osredotočenosti, agilnosti, jasnejšim poslovnim ciljem, večji donosnosti za delničarje in krepitvi svoje kulture za vse nas, sodelavce in sodelavke v Sandozu in Leku. To je vznemirljivo obdobje v naši zgodovini, ki nam bo vsem z ustvarjanjem nove in ambiciozne poti, nudila edinstveno priložnostna poklicnem in osebnem področju.

Na delovnem mestu
(senior) specialista za kontrolo kakovosti (QC) v bioanalitskem laboratoriju
boste imeli ključno vlogo pri njegovi vzpostavitvi, oblikovanju laboratorijskih procesov ter implementaciji analitskih metod. Gre za izjemno priložnost, saj boste aktivno soustvarjali temelje za uspešno delovanje laboratorija. Kot del dinamične in interdisciplinarne ekipe boste pridobili dragocena strokovna znanja ter prispevali k zagotavljanju skladnosti z regulatornimi zahtevami in visoki kakovosti bioanalitskih testov, ki podpirajo komercialne izdelke.

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka

Vaše Ključne Odgovornosti

• Aktivno sodelovanje pri obravnavi odstopanj (npr. rezultati izven specifikacij – OOX) ter vodenje in izvajanje korektivnih in preventivnih ukrepov (CAPA).
• Podpora pri prenosu analitskih metod: priprava dokumentacije, izobraževanje sodelavcev ter prenos strokovnega znanja.
• Pregled in odobritev analiz v skladu z GMP za namene analitskega sproščanja.
• Sodelovanje pri internih in zunanjih inšpekcijah.
• Priprava in revizija dokumentacije (standardni operativni postopki – SOP, delovna navodila – WP, kvalifikacija opreme in drugo).
• Dobro razumevanje bioloških testov in metode ELISA (Enzyme-Linked Immunosorbent Assay).
• Podpora sodelavcem pri vsakodnevnih nalogah in reševanju tehničnih izzivov.
• Aktivna vloga pri organizaciji in vzpostavitvi učinkovitega bioanalitskega laboratorija.

Vaš Doprinos k Delovnem Mestu

• Zaključena najmanj visokošolska 2. bolonjska stopnja naravoslovne smeri - biologija, biokemija, biotehnologija, mikrobiologija, laboratorijska biomedicina ali sorodno področje.
• Najmanj dve leti izkušenj v GMP okolju (za višjo – senior pozicijo vsaj pet let relevantnih izkušenj). Prednost imajo kandidati z izkušnjami v farmaciji in v oddelku za in v oddelku za kontrolo kakovosti. Zaželeno znanje in praktične izkušnje z delom s celičnimi kulturami.
• Aktivno znanje angleškega jezika (pisno in ustno).
• Računalniška pismenost.
• Visoka stopnja natančnosti, odgovornosti in sposobnost timskega dela, dobro razvite komunikacijske veščine, sposobnost samostojnega odločanja in učinkovitega reševanja problemov, prilagodljivost, proaktivnost in pripravljenost na stalno učenje.

Kaj Nudimo
Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj.

Možne lokacije dela:
Slovenija
(Lendava)

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

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do

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.