Vodja laboratorija mikrobiologije

Job Description Summary

Job Description

Pridružite se naši ekipi in prevzemite strateško vlogo pri vodenju mikrobiološkega laboratorija, ki je ključen za zagotavljanje kakovosti in skladnosti v proizvodnji zdravilnih učinkovin. Iščemo izkušenega strokovnjaka, ki bo z vizijo, znanjem in vodstvenimi sposobnostmi spodbujal kulturo odličnosti ter stalnih izboljšav.

Kot Vodja laboratorija mikrobiologije boste odgovorni za vodenje in razvijanje kadrov ter mikrobioloških procesov laboratorija, za nemoteno izvajanje kontrolnih aktivnosti s ciljem servisiranja kupcev, skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji. 

Pridružite se nam pri soustvarjanju "novega" Sandoza in Leka

Vaše ključne odgovornosti:

Glavne odgovornosti:

• Strateško vodenje in razvoj Mikrobiološkega laboratorija z namenom zagotavljanja nemotenega delovanja ter popolne skladnosti z zahtevami cGxP regulative.
• Nadzor in koordinacija mikrobioloških testiranj surovin, vmesnih produktov (IPC), zdravilnih učinkovin ter okoljskih vzorcev, skladno z vsemi varnostnimi, kakovostnimi in regulatornimi standardi.
• Zagotavljanje skladnosti z dobrimi laboratorijskimi praksami (GLP) ter izvajanje aktivnosti v skladu z nacionalno zakonodajo, evropskimi smernicami, FDA in drugimi relevantnimi regulatornimi organi. Aktivna podpora pri notranjih in zunanjih presojah ter inšpekcijskih pregledih.
• Vodenje preiskav odstopanj, OOX rezultatov in reklamacij ter sodelovanje pri oblikovanju in implementaciji korektivnih in preventivnih ukrepov (CAPA).
• Spodbujanje kulture stalnih izboljšav in operativne odličnosti znotraj mikrobiološkega oddelka.
• Upravljanje usposabljanj ter strokovni razvoj članov ekipe v skladu z zahtevami cGxP; spremljanje uspešnosti in zagotavljanje kompetenc.
• Nudenje strokovne podpore mikrobiološki kontroli kakovosti, proizvodnji in regulativnim zadevam, vključno s pripravo in oddajo dokumentacije.
• Usklajevanje operativnih aktivnosti oddelka ter zagotavljanje strokovne mikrobiološke podpore proizvodnim procesom in regulatornim zahtevam.

Vaš doprinos k delovnem mestu:

• Univerzitetna izobrazba iz mikrobiologije, farmacije, biotehnologije ali sorodnega področja.
• Minimalno 3 leta delovnih izkušenj na področju laboratorijskih procesov ali na podobni poziciji.
• Izkušnje na področju mikrobiologije v farmacevtski industriji, z dobrim poznavanjem cGxP in GLP.
• Vodstvene izkušnje in sposobnost razvoja ekipe.
• Odlično razumevanje regulatornih zahtev (EU, FDA) ter izkušenost z inšpekcijami in presojami.
• Analitične sposobnosti, proaktivnost in usmerjenost k reševanju problemov.
• Zelo dobro znanje angleškega jezika (pisno in ustno).

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. 

Lokacija dela: Lendava, Slovenija

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.  

#BIORampUp #Sandoz

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Join our team and take on a strategic leadership role in managing the Microbiology Laboratory, a key function ensuring quality and compliance in the production of biosimilars. We are looking for an experienced professional with vision, expertise, and leadership skills to foster a culture of excellence and continuous improvement.

As Quality Team Lead QC Microbiology you will be responsible for leading and developing both the team and microbiological processes, ensuring smooth execution of control activities to meet customer needs in full compliance with legislation, internal standards, good practices, and business objectives.

Be part of shaping the "new" Sandoz and Lek

Your key responsibilities:

Your responsibilities include, but not limited to:

• Strategic leadership and development of the Microbiology Laboratory to ensure seamless operations and full compliance with cGxP requirements.
• Oversight and coordination of microbiological testing of raw materials, intermediates (IPC), active pharmaceutical ingredients, and environmental samples in line with all safety, quality, and regulatory standards.
• Ensure compliance with Good Laboratory Practices (GLP) and activities aligned with national legislation, EU guidelines, FDA, and other relevant regulatory authorities. Provide active support during internal and external audits and inspections.
• Lead investigations of deviations, OOX results, and complaints, and collaborate on the design and implementation of corrective and preventive actions (CAPA).
• Promote a culture of continuous improvement and operational excellence within the microbiology department.
• Manage training programs and foster professional development of team members in line with cGxP requirements; monitor performance and ensure competency.
• Provide scientific support to microbiological quality control, manufacturing, and regulatory affairs, including preparation and submission of documentation.
• Coordinate operational activities of the department and ensure expert microbiological support for production processes and regulatory compliance. 

What you will bring to the role:

• University degree in Microbiology, Pharmacy, Biotechnology, or a related field.
• Minimum of 3 years of experience in laboratory processes or a similar role.
• Proven experience in microbiology within the pharmaceutical industry, with strong knowledge of cGxP and GLP.
• Leadership experience and ability to develop and motivate teams.
• Excellent understanding of regulatory requirements (EU, FDA) and experience with audits and inspections.
• Strong analytical skills, proactive mindset, and problem-solving orientation.
• Very good command of English (written and spoken).

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. 

Job location: Lendava, Slovenia 

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. 

#BIORampUp #Sandoz

Skills Desired