Vodja skupine kontrole kakovosti v medfazni analitiki (d/ž/m) / In-Process at SANDOZ INC

Lendava / Lendva, , Slovenia -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Quality Control, Analytical Methods, Regulatory Compliance, Organizational Skills, Communication Skills, Problem Solving, Team Development, Continuous Improvement, Laboratory Processes, Technical Leadership, Risk Assessment, Training Management, Documentation, Collaboration, Operational Excellence

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Prihodnost je v naših rokah! / The future is ours to shape. Job Description Iščemo izkušenega in zavzetega strokovnjaka za vodenje oddelka za kontrolo kakovosti v medfazni analitiki, ki bo s strateškim pristopom in operativno odličnostjo zagotavljal visoke standarde kakovosti v proizvodnji učinkovin za podobna biološka zdravila. V tej vlogi boš odgovoren/-na za nemoteno delovanje laboratorija, skladnost z regulativo (cGxP, GLP, EU, FDA), razvoj in vzdrževanje analitskih metod ter vodenje visoko usposobljene ekipe. Če te odlikujejo vodstvene sposobnosti, natančnost in strast do kakovosti, te vabimo, da se nam pridružiš pri soustvarjanju prihodnosti bioloških zdravil. Kot Vodja skupine kontrole kakovosti v medfazni analitiki boste odgovorni za vodenje in razvijanje kadrov ter procesov kontrole kakovosti oz. 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: Vodenje, organizacija in strateški razvoj oddelka medfazne analitike z namenom zagotavljanja nemotenega poteka analiz v proizvodnem procesu ter skladnosti z zahtevami cGxP. Nadzor nad izvajanjem medfaznih (in-process) analiz v proizvodnji bioloških učinkovin za zagotavljanje kakovosti, procesne konsistence in skladnosti z regulativnimi zahtevami. Pravočasen pregled, potrditev in sprostitev medfaznih analitskih rezultatov, vključno z ustrezno laboratorijsko in procesno dokumentacijo. Skrb za skladnost z GLP, cGMP/cGxP ter zakonodajo RS, EU, FDA in drugih regulatorjev, ter aktivna podpora pri notranjih in zunanjih presojah, inšpekcijah in kvalifikacijskih projektih. Vzdrževanje, optimizacija in posodabljanje analitskih metod za medfazno kontrolo, ter priprava in posodabljanje SOP-jev, delovnih navodil in tehnične dokumentacije. Zagotavljanje kvalifikacije, kalibracije in rednega vzdrževanja laboratorijske ter procesne analitske opreme, vključno s sistemom za spremljanje in upravljanje opreme. Vodenje preiskav odstopanj, OOX rezultatov, reklamacij in triaž procesnih anomalij, ter sodelovanje pri pripravi in izvajanju CAPA aktivnosti. Spodbujanje kulture stalnih izboljšav, digitalizacije in operativne odličnosti znotraj medfazne analitike ter širšega QC/QM področja. Upravljanje usposabljanj, periodičnih preverjanj znanja in razvoja kompetenc članov ekipe v skladu z zahtevami cGxP in potrebami proizvodnih procesov. Krepitev medoddelčnega sodelovanja, zlasti z operacijami, tehnologijo, zagotavljanjem kakovosti in razvojem procesov, ter aktivno spodbujanje kulture kakovosti, varnosti in skladnosti v celotni organizaciji. Vaš doprinos k delovnem mestu: Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikorbiološke ali druge naravoslovne smeri. Minimalno 3 leta delovnih izkušenj na področju laboratorijskih procesov ali podobnih pozicij. Aktivno znanje angleškega jezika (ustno in pisno). Izkušnje z vodenjem ali koordinacijo manjše laboratorijske ali projektne ekipe, mentoriranjem sodelavcev ali tehničnim vodenjem analitskih aktivnosti. Odlične organizacijske sposobnosti ter sposobnost učinkovitega načrtovanja, prioritetiranja in razporejanja laboratorijskih/operativnih nalog. Razvite komunikacijske veščine za delo z različnimi deležniki (QC, QA, Proizvodnja, AS&T, razvoj). Samostojno odločanje in reševanje tehničnih izzivov, zmožnost hitre ocene tveganj ter predlaganja izvedljivih rešitev. 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. 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 01. marca 2026 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 20.000 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 ______________________________________________________________________________________________________________________________________________________________________________ We are looking for an experienced and dedicated professional to lead our In-Process (IPC) department, ensuring operational excellence and regulatory compliance in the production of active pharmaceutical ingredients for biosimilars. In this strategic role, you will be responsible for the smooth daily operation of the IPC lab, adherence to cGxP, GLP, EU, and FDA regulations, development and maintenance of analytical methods, and leadership of a skilled team. If you are a detail-oriented leader with a passion for quality, we invite you to join us in shaping the future of biopharmaceuticals. As Quality Team Leader IPC you will be responsible for leading and developing both the team and the in-process control (IPC) processes. Your main goal will be to ensure the smooth execution of control activities in line with customer needs, applicable legislation, internal procedures, good practices, and overall business objectives. Join us as a Founder of our ‘new’ Sandoz and Lek! Your key responsibilities: Your responsibilities include, but not limited to: Leading and strategically developing the In-Process (IPC) department to ensure smooth excecution of analyses withing the manufacturing process and full compliance with cGxP regulatory requirements. Overseeing the execution of in‑process analytical testing in the manufacture for biosimilars to ensure product quality and regulatory compliance. Ensuring timely review, approval, and release of in-process analytical results, including associated laboratory and process documentation. Ensuring compliance with Good Laboratory Practices (GLP) and the legislation of the Republic of Slovenia, EU, FDA, and other relevant regulatory bodies; actively supporting internal and external audits and inspections. Maintaining and updating analytical methods used for in-process control, standard operating procedures (SOPs), and work instructions in accordance with cGxP guidelines. Ensuring qualification, calibration, and regular maintenance of laboratory equipment. Leading investigations of deviations, OOX results, and complaints, and contributing to the development and implementation of corrective and preventive actions (CAPA). Promoting a culture of continuous improvement and operational excellence within the IPC and across the broader QC/QM organization. Managing training, monitoring performance, and supporting the professional development of team members in line with cGxP requirements. Strengthening cross-functional collaboration and fostering a culture of quality, safety, and compliance across the organization. What you will bring to the role: University degree in Pharmacy, Biology, Chemistry, Microbiology, or another related natural science field. Minimum of 3 years of professional experience in laboratory processes or in a comparable position. Proficient command of English, both written and spoken. Experience in leading or coordinating a (small) laboratory or project team, mentoring colleagues, or providing technical leadership in analytical activities. Excellent organizational skills with the ability to effectively plan, prioritize, and manage laboratory/operational workflows. Strong communication skills for collaboration with multiple stakeholders (QC, QA, Manufacturing, AS&T, Development). Ability to make independent decisions and resolve technical challenges, quickly assess risks, and propose feasible solutions. 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. Job location: Lendava, Slovenia We offer permanent contract with 6-month probation period. You are kindly invited to submit your application in English language, including CV, by March 1st, 2026. 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 Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!

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Responsibilities

The In-Process Control Team Leader will oversee the execution of in-process analytical testing and ensure compliance with regulatory requirements. They will also lead and develop the team while maintaining high standards of quality in the laboratory.