Resumen
Kot Tehnolog proizvodnih procesov I boste odgovorni za zagotavljanje strokovne pomoči proizvodnji, obvladovanju in optimizacije proizvodnih procesov ter upravljanje procesnih tehnologij in izdelkov.
Sodelovali boste pri stalnem izboljševanju kakovosti in produktivnosti proizvodnih procesov, v skladu s trenutno veljavnimi GMP smernicami, SPji splošnimi postopki ter ostalimi veljavnimi smernicami in funkcijskimi standardi (npr. ZVO). Podpirali boste nemoteno delovanje proizvodnje, s ciljem izboljšati kakovost in skladnost.
Odgovorni boste za nadgradnjo in prenos strokovnih znanj, vrednotenje implementacijo novih tehnologij prispevajo k optimizaciji procesov.
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We are seeking a Process Expert I. In this role, you will be provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE...). Support smooth operation of production, with the aim of improving quality and compliance. Responsibility for upgrading and transfer of expertise, assessment and implementation of new technologies, and contribution to the development process optimization.
About the Role
Vaše ključne odgovornosti:
- Zagotavljanje strokovne podpore za kompleksna vprašanja in izzive, povezane s procesi in proizvodnjo.
- Opravljanje vloge strokovnjaka na svojem področju (SME) za specifične tehnike, izdelke ali tehnološke procese.
- Usklajevanje in zagotavljanje pravočasnega dokončanja vseh proizvodnih postopkov v skladu z dokumentacijo in pravili dobre proizvodne prakse (GMP).
- Zagotavljanje pravočasne strokovne podpore proizvodnji v primeru tehničnih težav in skrb za takojšnje izvajanje ustreznih korektivnih ukrepov.
- Spremljanje kompleksnih procesov in ugotavljanje morebitnih trendov ter pravočasno ukrepanje ob opaženih negativnih trendih.
- Zagotavljanje sistematičnega ter pravočasnega posodabljanja kompleksne proizvodne dokumentacije za potrebe redne proizvodnje, projektnih časovnic in/ali validacij skladno z zahtevami GMP.
- Skrb za prenos informacij in povečanje ozaveščenosti timov v proizvodnji ob težavah ali spremembah, ki imajo vpliv na tehnične dejavnike, kakovost ali ZVO.
- V primeru imenovanja izvajanje usposabljanj in izobraževanj.
- Skrb za prenos znanja.
- Udeležba na vseh usposabljanjih oz. izobraževanjih, ki so zahtevana za to delovno mesto, shranjevanje ustreznih dokazil o usposabljanju.
Vaš doprinos k delovnem mestu:
- Najmanj univerzitetna diploma iz inženiringa, farmacevtske tehnologije, kemije, farmacije ali druge podobne znanstvene smeri.
- Zaželen magisterij ali ustrezne izkušnje.
- Aktivno znanje angleškega jezika in znanje lokalnega jezika.
- Poznavanje orodij Microsoft Office.
- Na delovnih mestih za podporo procesom v proizvodnji.
- Poznavanje procesov (farmacevtska proizvodnja, GMP, regulatorni vidiki).
Zaželene izkušnje:
- Poznavanje proizvodnih procesov (farmacevtska proizvodnja, GMP, regulatorni vidiki).
- Vozniški izpi B kategorije Zaželjene delovne izkušnje za podporo procesom v proizvodnji.
Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
Kaj nudimo:
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.
Predani smo raznolikosti in vključenosti
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
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Key Responsibilities:
- Provide front line expert support for complex issues and challenges, related to processes and production.
- Act as Subject Matter Expert (SME) for specific techniques, products or technical processes.
- Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP.
- Ensure on time shop floor support as an expert on technical problems and ensuring that appropriate immediate corrective actions are implemented.
- Monitor complex processes, identify possible trends and ensure timely interventions in the event of observed negative trends.
- Ensure that all of the complex production documents, project timelines and/or validations are systematically and timely up to date for the need of regular production, in compliance with GMP.
- Transfer of information and increase awareness of production teams following problems or modifications having a technical, quality or HSE impact.
- If nominated, carry out trainings.
- Knowledge transfer and mentoring of associates.
- Participation in all training relevant to the position, maintenance of the relevant training evidence.
Essential Requirements:
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience.
- Fluent in English and proficient in site local language.
- Knowledge of Microsoft Office.
- Minimum 3-year experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
Desirable Requirements:
- Knowledge of production processes (pharmaceutical production, GMP, regulatory aspects).
- Driving license B category.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
You’ll receive:
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 (Wellbeing), Unlimited learning and development opportunities.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
