QA Engineer
Associate Expert Drug Supply
Mengešfulltime
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Summary
Strokovni sodelavec za oskrbo zdravil (m/ž/d) / Associate Expert Drug Supply (m/f/d)
About The Role
Strokovni sodelavec za oskrbo zdravil (m/ž/d) / Associate Expert Drug Supply (m/f/d)
Z veseljem napovedujemo ustanovitev novega obrata klinične proizvodnje v Sloveniji, namenjenega hitrejšemu odkrivanju inovativnih zdravil za bolnike po vsem svetu. Najsodobnejši objekt, ki se nahaja v Biocampusu v Mengšu, nudi izjemno priložnost za sodelovanje, inoviranje in vpliv.
V okviru klinične proizvodnje bioloških učinkovin iščemo sodelavca oziroma sodelavko za delo na področju inprocesne analitike proizvodnega procesa bioloških učinkovin.
Primarna odgovornost delovnega mesta je priprava, izvedba in dokumentiranje inprocesne analitike za podporo proizvodnji bioloških učinkovin. Vaše zadolžitve bodo vključujevale delo z različno analitsko opremo ter analitskimi metodami, uporabo aplikacije GLIMS, vodenje in pregled analitske dokumentacije, pregled rezultatov ter skrb za urejeno, skladno in učinkovito delovanje analitskega laboratorija.
Če vas veseli delo v analitskem laboratoriju, hkrati pa cenite dinamično okolje in neposredno povezavo s proizvodnjo, je ta pozicija odlična priložnost za vaš strokovni razvoj.
Postanite del zavzetega tima, ki soustvarja prihodnost medicine in prispeva k razvoju terapij za bolnike po vsem svetu. Veselimo se kandidatov, ki želijo s svojim znanjem in izkušnjami prispevati k uspešni vzpostavitvi in delovanju klinične proizvodnje v Sloveniji.
Vaše Ključne Odgovornosti
- priprava, izvedba in dokumentiranje inprocesne analitike proizvodnje bioloških učinkovin;
- planiranje, izvajanje in dokumentiranje aktivnosti v skladu z zahtevami GxP;
- izpolnjevanje in pregled GxP dokumentacije, vključno z dnevniki, obrazci, proizvodnimi poročili in izvornimi podatki;
- priprava enostavnih postopkov, protokolov in poročil, kot so delovni postopki in poročila o trendih;
- sodelovanje pri obravnavi odstopanj, reševanju težav ter izvajanju korektivnih in preventivnih ukrepov;
- skrb za skladno, urejeno in varno delo v analitskem laboratoriju ter dosledno upoštevanje predpisov, internih postopkov in standardov kakovosti;
- delovanje v skladu s standardi na področju kakovosti, etike, varnosti, zdravja, okolja in informacijske varnosti;
- aktivno prispevanje k pozitivni delovni kulturi ter lastnemu strokovnemu in osebnemu razvoju.
Vaš Doprinos k Delovnemu Mestu
- zaključena najmanj srednješolska izobrazba ustrezne smeri;
- aktivno znanje slovenskega jezika in tehnično znanje angleškega jezika;
- dobre organizacijske sposobnosti ter natančnost pri vodenju in upravljanju dokumentacije v skladu s pravili podjetja;
- sposobnost doslednega upoštevanja navodil, postopkov in standardov dela;
- osnovno oziroma ustrezno poznavanje računalniških orodij in programske opreme, relevantne za delo.
Zaželene Izkušnje
- izkušnje na primerljivem delovnem mestu v proizvodnem ali analitskem okolju;
- strokovno ali tehnično znanje s področja naravoslovnih ved;
- poznavanje dobre proizvodne prakse (GMP) in izkušnje z delom v reguliranem okolju.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo šestih mesecev. Prijavo oddajte skupaj z življenjepisom v slovenskem in angleškem jeziku.
Koristi in nagrade
V Novartisu smo zavezani skupnemu preoblikovanju medicine – in nagrajevanju ljudi, ki jo uresničijo.
Pričakovana letna osnovna plača Razpon za delovno mesto:
€20.300
do
€37.700
Osnovna plača je določena glede na spolno nevtralne cilje, kot so relevantne veščine, kompetence in izkušnje v skladu s politiko plač Novartisa, ob vstopu v Novartis pa se redno pregleduje.
Poleg osnovne plače ste morda upravičeni do bonusa na podlagi uspešnosti, odvisno od določenih parametrov uspešnosti.
Nagrade, ki jih prinaša članstvo v naši ekipi, segajo daleč preko osnovne plače in spodbud. Ponujamo tudi različne konkurenčne ugodnosti v naravi, ki vam pomagajo uspevati osebno in poklicno, kot so zavarovalni načrti, pokojninski načrti, viri za dobro počutje in globalni programi priznanja. Poleg tega ponujamo prilagodljive in hibridne možnosti dela, kjer je mogoče, ter najmanj 14 tednov plačanega starševskega dopusta.
Associate Expert Drug Supply (m/f/d) / Strokovni sodelavec za oskrbo zdravil (m/ž/d)
We are pleased to announce the establishment of a new clinical manufacturing facility in Slovenia, dedicated to accelerating the discovery and development of innovative medicines for patients worldwide. This state-of-the-art facility, located at Biocampus in Mengeš, offers an exceptional opportunity for collaboration, innovation, and impact.
Within clinical manufacturing of biological drug substances, we are looking for an associate to work in the field of in-process analytics supporting the biological drug substance clinical manufacturing process.
The primary responsibility of this role is the preparation, execution, and documentation of in-process analytics in support of biological drug substance production. The role includes the use of the GLIMS application, completion and review of analytical documentation, review of results, and ensuring an organized, compliant, and efficient analytical laboratory environment.
If you enjoy working in an analytical laboratory and value a dynamic environment with a direct connection to manufacturing, this position offers an excellent opportunity for your professional development.
Join a dedicated team that is helping reimagine medicine and contributing to the development of therapies for patients worldwide. We look forward to welcoming candidates who would like to contribute their knowledge and experience to the successful establishment and operation of clinical manufacturing in Slovenia.
Your Key Responsibilities
- Preparation, execution, and documentation of in-process analytics in support of biological drug substance production;
- Planning, execution, and documentation of activities in accordance with GxP requirements;
- Completion and review of GxP documentation, including logbooks, forms, production records, and raw data;
- Preparation of simple procedures, protocols, and reports, such as working procedures and trending reports;
- Participation in deviation handling, troubleshooting, and implementation of corrective and preventive actions;
- Ensuring compliant, organized, and safe work in the analytical laboratory, with consistent adherence to regulations, internal procedures, and quality standards;
- Working in accordance with standards related to quality, ethics, safety, health, environment, and information security;
- Actively contributing to a positive work culture as well as to personal and professional development.
What You Will Bring To The Role
- Completed at least secondary-level education in a relevant field;
- Fluent knowledge of Slovenian and technical knowledge of English;
- Good organizational skills and accuracy in maintaining and managing documentation in line with company requirements;
- Ability to consistently follow instructions, procedures, and work standards;
- Basic or appropriate knowledge of computer tools and software relevant to the role.
Desirable Experience
- Experience in a comparable role within a manufacturing or analytical environment;
- Professional or technical knowledge in the field of natural sciences;
- Knowledge of Good Manufacturing Practice (GMP) and experience working in a regulated environment.
The selected candidate will be offered long-term employment with a six-month probation period. Please submit your application together with a CV in Slovenian and English.
Benefits And Rewards
At Novartis, we are committed to reimagining medicine together—and rewarding the people who make it happen.
Expected annual base salary range for this position:
€20.300
do
€37.700
Base salary is determined using gender-neutral criteria such as relevant skills, competencies, and experience, in accordance with Novartis compensation policies, and is reviewed regularly after joining Novartis.
In addition to the base salary, you may be eligible for a performance-based bonus, depending on established performance criteria.
The rewards of being part of our team extend far beyond base pay and incentives. We also offer a variety of competitive benefits designed to support your personal and professional well-being, including insurance plans, retirement plans, wellness resources, and global recognition programs.
In addition, we offer flexible and hybrid working arrangements where possible, as well as a minimum of 14 weeks of paid parental leave.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture
Benefits and Rewards:
Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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