QC Specialist Microbiology II

Job Description Summary

The future is ours to shape. / Prihodnost je tu, oblikujmo jo skupaj.

Job Description

In Lek's microbiology laboratory, we are looking for a dedicated professional to take on a key role in ensuring the quality of our products. As a QC Specialist Microbiology, you will be responsible for performing bacterial endotoxin testing and microbiological analytics, writing protocols and procedures, and validating analytical methods.

Your role will also include close collaboration with analysts—taking ownership of your area, coordinating and planning work—as well as conducting deviation investigations. You will be responsible for analytical equipment, preparing instructions for process documentation, reviewing and approving analyses, and supporting inspections.

This is a responsible and technically diverse position where your expertise will directly contribute to the quality of our processes and products. You'll work closely with cross-functional teams, gaining insight into the complexity of pharmaceutical manufacturing and expanding your professional knowledge.

If you're looking for work with clear purpose and real impact, we invite you to join us.

Your key responsibilities:

Your responsibilities include, but not limited to:

• Investigating analytical deviations and implementing preventive/corrective actions
• Ensuring all activities comply with current Good Practices, including data integrity
• Reviewing and approving analytical data/tests (analytical sample release)
• Responsibility for validation and troubleshooting of analytical methods in line with requirements, and supporting the implementation of new methods and techniques
• Participating in the selection of new equipment, maintaining laboratory equipment, and ensuring team members are properly trained
• Responsibility for preparing and revising general and working procedures, certificates of analysis, and analytical and registration documentation
• Ensuring proper processing and archiving of analytical documentation
• Supporting inspection readiness within your area of responsibility and communicating with analytical stakeholders

What you will bring to the role:

• University degree in microbiology, biochemistry, biotechnology, pharmacy, chemistry, or another natural science field
• Active knowledge of English and fluent knowledge of Slovenian
• Previous work experience in quality, development, production, or other related areas is an advantage
• Proficiency in using Microsoft Office tools

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 (WellBeat), Unlimited learning and development opportunities. 

Possible job locations: Slovenia (Ljubljana).

We offer a temporary contract (with the possibility of extension) with a 6-month 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

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V mikrobiološkem laboratoriju Lek iščemo strokovnjaka/-injo, ki bo prevzel/-a pomembno vlogo pri zagotavljanju kakovosti naših izdelkov. Kot specialist/-ka za mikrobiološki nadzor kakovosti boš odgovoren/-na za izvajanje bakterijskega endotoksinskega testa in mikrobiološke analitike, pisanje protokolov in postopkov ter validacijo metod.

Tvoje delo bo vključevalo tudi tesno sodelovanje z analitiki – skrb za svoje področje, koordinacijo in načrtovanje dela – ter izvedbo raziskav v primeru odstopanj. Prevzel/-a boš odgovornost za analitsko opremo, pripravljal/-a navodila za procesno dokumentacijo, pregledoval/-a in overjal/-a analize ter sodeloval/-a pri inšpekcijah.

Gre za odgovorno strokovno vlogo, kjer boš s svojim znanjem neposredno prispeval/-a k kakovosti procesov in izdelkov. Delo poteka v sodelovanju z različnimi ekipami, kar omogoča širjenje znanja in vpogled v kompleksnost farmacevtske proizvodnje.

Če te zanima delo, ki ima jasen namen in vpliv, te vabimo, da se nam pridružiš.

Vaše ključne odgovornosti:

• Reševanje analitskih odstopanj in izvajanje preventivnih/korektivnih ukrepov
• Zagotavljanje, da so vse aktivnosti skladne z veljavnimi dobrimi praksami, vključno z integriteto podatkov
• Pregled in odobritev analitskih podatkov/testov (analitska sprostitev vzorcev)
• Odgovornost za validacijo in odpravljanje težav pri analitskih metodah v skladu z zahtevami ter podpora pri uvajanju novih metod in tehnik
• Sodelovanje pri izbiri nove opreme, vzdrževanju laboratorijske opreme in zagotavljanje usposobljenosti sodelavcev za delo
• Odgovornost za pripravo in revizijo splošnih in delovnih postopkov, certifikatov o analizi, analitske in registracijske dokumentacije
• Zagotavljanje ustrezne obdelave in arhiviranja analitske dokumentacije
• Podpora pri stalni pripravljenosti na inšpekcije na svojem področju odgovornosti in komunikacija z naročniki analiz

Vaš doprinos k delovnem mestu:

• Univerzitetna izobrazba iz mikrobiologije, biokemije, biotehnologije, farmacije, kemije ali druge naravoslovne smeri.
• Aktivno znanje angleškega jezika in tekoče znanje slovenskega jezika
• Zaželeno delovno iskustvo na področju kakovosti, razvoja, proizvodnje ali drugih sorodnih področjih
• Znanje uporabe Microsoft Office orodi

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 (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj. 

Možne lokacije dela: Slovenija (Ljubljana).

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas (z možnostjo podaljšanja) 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.  

#Sandoz

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management

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