Ekspert upravljanja kakovosti – skladnost

Job Description Summary

#LI-Hybrid
Lokacija: Ljubljana, Slovenija

Vas navdušuje kakovost in skladnost v dinamičnem farmacevtskem okolju? Kot strokovnjak za skladnost kakovosti boste zagotavljali, da Novartis izpolnjuje najvišje standarde GxP in regulativne zahteve—podpirali boste revizije, vzpostavljali kakovostne sisteme in zagotavljali integriteto izdelkov. Vaš vpliv se bo odrazil tako na poslovanju kot na rezultatih za paciente.

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Are you driven by quality and compliance in a fast-paced pharma setting? As a QA Compliance Expert, you'll ensure Novartis meets top GxP and regulatory standards—supporting audits, driving quality systems, and safeguarding product integrity. Your impact will be felt across operations and patient outcomes.

 

Job Description

Vaše ključne odgovornosti:

• Vzpostavitev in vzdrževanje kakovostnih sistemov, vključno z upravljanjem dokumentacije
• Podpora pri upravljanju sprememb,
• Podpora in pomoč pri izvedbi aktivnosti povezanih z regulativnimi zahtevami na lokaciji ob lansiranju in zdrževanju farmacevtskih izdelkov.
• Priprava in podpora pri revizijah, inšpekcijah ter koordinaciji CAPA
• Aktivno sodelovanje v internih in eksternih pregledih ter prispevanje k stalnemu izboljšanju sistemov kakovosti in skladnosti
• Spremljanje kazalnikov skladnosti in zagotavljanje pripravljenosti na interakcije z zdravstvenimi organi

Vaš doprinos k delovnem mestu:

• Visokošolska izobrazba s področja farmacije, kemije, biokemije ali druge ustrezne tehnične smeri
• Vsaj 2–3 leta izkušenj na področju proizvodnje, razvoja, kakovosti ali regulatorne skladnosti v farmacevtski industriji
• Izkušnje z upravljanjem sistemov kakovosti in presojami.
• Sposobnost prepoznavanja tveganj, sprejemanja odločitev in nenehnega izboljševanja
• Odlične komunikacijske in organizacijske sposobnosti v medfunkcionalnih timih
• Tekoče znanje angleščine
• Dobro poznavanje zakonodaje in regulativnih zahtev v Sloveniji in Svetu.

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas enega leta s poskusno dobo 6 mesecev. 

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 indružbenega počutja (Polni življenja) ter dogodki in 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.

Dostop in prilagoditve  

V Novartisu si prizadevamo k vključenosti oseb z invalidnostjo in zagotavljanju ustreznih prilagoditev delovnega okolja posameznikom z omejitvami. V kolikor zaradi bolezni ali invalidnosti potrebujete ustrezne prilagoditve v kateremkoli delu selekcijskega procesa oziroma potrebujete prilagoditve pri izvajanju osnovnih nalog na delovnem mestu, nam pišite na naslov in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate. 

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Key Responsibilities

• Supporting activities for change management
• Establishing and maintaining quality systems, including documentation management
• Supporting and facilitating activities related to regulatory requirements at the site during product launch and maintenance
• Prepare and support audits, inspections, and CAPA coordination
• Active participation in internal and external reviews and contributing to continuous improvement of quality and compliance system
• Monitor compliance metrics and ensure readiness for Health Authority interactions

Essential Requirements

• University degree in Pharmacy, Chemistry, Biochemistry, or another relevant technical/scientific field
• At least 2–3 years of experience in Production, development or Quality Assurance and regulatory compliance in  the pharmaceutical industry
• Experience in managing quality systems and audits
• Ability to identify risks, make decisions, and drive continuous improvement
• Excellent communication and organizational skills in cross-functional teams
• Fluent in English
• Good knowledge of legislation and regulatory requirements in Slovenia and Worldwide

The selected candidate will be offered a 1 year temporary contract with a 6-month probation period.

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 (Energized for Life), 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.

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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 

 

Skills Desired

Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise

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