Job Description Summary
Kot Vodja kontrole kakovosti (QC Lead) boste vodili laboratorije za nadzor kakovosti na naši lokaciji v Mengšu. Vaša glavna naloga bo zagotavljanje skladnosti laboratorijskih dejavnosti in povezanih sistemov kakovosti z vašim strokovnim področjem, internimi predpisi, dobrimi praksami ter smernicami iz Novartisovega priročnika kakovosti. Prav tako boste skrbeli za usklajenost z vsemi veljavnimi regulativnimi in zakonodajnimi zahtevami skozi celoten življenjski cikel izdelkov.
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We are looking for a QC Lead to manage the Site Quality Control laboratories. In this role, you will ensure that all laboratory activities and associated Quality systems adhere to internal regulations, industry best practices, the Novartis Quality Manual, and applicable regulatory and legislative requirements. Your leadership will be crucial in maintaining compliance and upholding quality standards throughout the entire product lifecycle.
Job Description
Vaše ključne odgovornosti:
- Zagotavljanje izvajanja aktivnosti KK v skladu s standardi cGxP.
- Nadzor nad pravočasnim testiranjem vzorcev za zagotavljanje nemotenih proizvodnjih procesov
- Zagotavljanje skladnosti operacij analitičnih laboratorijev in razvoja z veljavnimi regulativnimi zahtevami in smernicami.
- Iskanje priložnosti za izboljšanje produktivnosti in usklajevanje njihove izvedbe.
- Doseganje ključnih kazalnikov uspešnosti (KPI) v zvezi s kakovostjo, stroški in ljudmi
- Omogočanje pravočasnega sproščanja izdelkov v skladu z GMP (Good Manufacturing Practice) in regulatornimi zahtevami.
- Upoštevanje in izvajanje pravil ter smernic za področje zdravja, varnosti in okolja (ZVO).
Vaš doprinos k delovnem mestu:
- Spretnost prilagajanja spreminjajočim se prioritetam in okoljem.
- Vodenje presoj
- Močno razumevanje poslovne strategije in njene uporabe v operacijah QC.
- Zavezanost odličnosti v laboratoriju in spoštovanju najboljših praks.
- Obvladovanje principov in metod nadzora kakovosti.
- Spretnost v upravljanju deležnikov za usklajevanje ciljev različnih funkcij.
- Aktivno znanje angleškega jezika (pisno in ustno).
Zaželene izkušnje:
- Izkušnje v vodenju ljudi, z zmožnostjo motiviranja in usmerjanja ekipe.
- Minimalno 5 let delovnih izkušenj na področju kakovosti, razvoja, proizvodnje v farmacevtski industriji ali na primerljivih delovnih mestih
- Visokošolska stopnja izobrazbe farmacevtske, biološke, kemijske, mikrobiološke ali druge naravoslovne smeri.
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, zaposlitev v podjetju s certifikatom TOP Employer, 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:
- Ensure QC activities are executed in accordance with cGxP standards.
- Oversee the on-time testing of samples to maintain workflow efficiency.
- Ensure compliance of analytical laboratory operations and development with applicable regulatory requirements and guidelines.
- Identify opportunities for productivity improvements and coordinate their implementation.
- Achieve KPIs related to quality, cost, people, and delivery.
- Facilitate timely product release in line with GMP (Good Manufacturing Practice) and license requirements.
- Maintain a safe work environment with zero HS&E (Health, Safety & Environment) incidents.
Essential Requirements:
- Agility in adapting to changing priorities and environments.
- Experience with audit management and ensuring compliance readiness.
- Strong understanding of business strategy and its application to QC operations.
- Commitment to laboratory excellence and adherence to best practices.
- Proficiency in quality control principles and methods.
- Skilled in stakeholder management to align cross-functional goals.
- Active knowledge of English (written and spoken).
Desirable Requirements:
- Proven experience in people leadership, with the ability to motivate and guide teams.
- Over 5 years of experience in QA/QC/Production or related fields.
- University degree in pharmacy, biology, chemistry, microbiology or other natural science degree
We are offering a permanent employment contract, including a 6-month 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), employment at Top SI Employer, 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.
Skills Desired
Agility, Agility, Audit Management, Business Acumen, Business Partnering, Business Strategy, Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Finance Acumen, Health Authorities, Knowledge Of Gmp, Laboratory Excellence , Leadership, Manufacturing Production, Organizational Savvy, People Management, Product Release, Qa (Quality Assurance), Quality Control, Quality Management, Quality Management Systems (QMS), Root Cause Analysis (RCA), Self-Awareness, Six Sigma {+ 4 more}
