摘要
_____________
We are seeking a Site MS&T Head. In this role, you will be lead the Site’s MS&T organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant technical knowledge and capabilities at the Site and to ensure the product and technical stewardship, across process units and functions at Site, in accordance with the law, good practices and business objectives.
About the Role
Vaše ključne odgovornosti:
- Opredeljevanje in uvajanje standardov za MS&T ter zagotavljanje splošne pripravljenosti na inšpekcijske preglede za omenjeno področje.
- Zagotavljanje nadzora nad tehničnimi spremembami ter vodenje celotnega procesa upravljanja kontrole sprememb v zvezi z določenimi tehničnimi problemi, pri tem pa po potrebi sodelovanje z ostalimi funkcijami.
- Skrb za to, da se pri investicijskih projektih upošteva tehnično strokovno znanje za uporabo proizvodne opreme.
- Skrbništvo nad glavnim načrtom validacije (VMP) (priprava in vzdrževanje).
- Skrbeli boste, da so vsi procesi proizvodnje, pakiranja in čiščenja validirani ter v stalnem stanju validiranosti ves čas življenjskega cikla.
- Odgovorni boste za aktivnosti prenosov tehnologij na lokacijo ali iz nje ter zagotavljanje ustreznega povečanja zmogljivosti proizvodnje za namen trženja novih izdelkov (scaleup).
- Zagotavljali boste, da ima lokacija na voljo ustrezne tehnične standarde za procese, pakiranje in materiale ter da jih dosledno upošteva (npr. vgrajena kakovost Quality by designQbD, načrtovanje eksperimentov, procesna analitska tehnologija PAT).
- Ostale naloge določene s pogovorom o ciljih in s kazalniki uspešnosti.
Vaš doprinos k delovnem mestu:
- Magisterij znanstvene ali farmacevtske smeri ali magisterij iz kemijskega inženiringa ali farmacevtske tehnologije ali ustrezne izkušnje. Zaželen doktorat iz omenjenih smeri.
- Aktivno znanje angleškega jezika
- Minimalno 10 let izkušenj v proizvodnji. Dodatne specialistične izkušnje zaželene (npr. farmacevtske formulacije, razvoj procesov, proizvodna tehnologija).
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen 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.
________________________
Key Responsibilities:
- Define and implement standards for MS&T and ensure overall inspection readiness for area of responsibility.
- Ensure oversight of technical changes and lead end-to-end change control management related to relevant technical issues, working cross-functionally as required.
- Ensure technical expertise for manufacturing equipment operation is considered for investment projects.
- Ownership of the site Validation Master Plan (VMP) (creation and maintenance).
- Ensure all manufacturing, packaging and cleaning processes are validated and ongoing verification is implemented, so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
- Accountable for technical transfer activities into, within and out of the site, and ensure appropriate increase in production with aim to commercialize scale-up of new products.
- Ensure the site has set and rigorously applies appropriate technical standards for processing, packaging and materials, where applicable, employing new/modern processes and technologies (e.g. Quality by design-QbD, planning experiments, process analytics technology PAT).
- Other tasks determined during the objectives setting process and by KPIs.
Essential Requirements:
- MSc. in Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.D. desirable.
- Functional knowledge of English.
- Minimum 10 years’ experience in manufacturing. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
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.
