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Quality Assurance Specialist - Temporary Contract

Company:
Roche
Location:
Ljubljana, Slovenia
Posted:
April 29, 2025
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Description:

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche employs over 100,000 people, working together in more than 150 countries. We are the world's leading research-focused biotechnology company. Our success is based on innovation, curiosity and diversity.

In the License to Operate Department, we are looking for a Quality Assurance Specialist, who will work with colleagues to create great experiences for our customers.

Work is for a fixed period (12 to 18 months).

If you have experience in quality management, enjoy working with people and want to work in a dynamic and changing environment of a multinational company, we invite you to join us in our mission.

Your Impact:

Maintenance of quality system and compliance with requirements of good distribution and good manufacturing practice.

Performance of activities necessary for quality assurance and quality control of the reception, storage, dispensing and transport of medicinal products and medical devices, and the inspection of documentation and the assurance of batch traceability.

Handling complaints about the quality of medicines and issues relating to the quality of medicines.

GMP/GDP change management

Management of GMP/GDP non-compliance

Control of documentation in an electronic documentation system.

Who are you:

You hold a Master of Pharmacy

You have an experience in a comparable workplace

You are skilled in managing complex systems and processes with an emphasis on drug quality management

You are an excellent teammate in multifunctional groups

You have the ability to adapt rapidly to changes or expectations encountered

You possess a proactive and positive mindset

You have active written and oral knowledge of the Slovenian language and good written and oral expression and understanding in English

You are knowledgeable of tools and software such as Google Workspace, MS Office or similar

At Roche you can find more than just a job. We are a community that values innovation, cooperation and commitment to making real change. With your knowledge, experience and commitment, you can together with us create good experiences that will continue to excel us.

Strokovni sodelavec v oddelku Upravljanja kakovosti in regulative m/ž

Objava delovnega mesta

V Rochu zaposlujemo prek 100.000 ljudi, ki skupaj delujejo v več kot 150 državah. Smo vodilno biotehnološko podjetje na svetu, ki se osredotoča na raziskave. Naš uspeh temelji na inovativnosti, radovednosti in raznolikosti.

V oddelku Upravljanje kakovosti in regulative iščemo novega sodelavca/ko za upravljanje kakovosti in regulative, ki bo skupaj s kolegi ustvarjal odlične izkušnje za naše stranke.

Delo je za določen čas (12-18 mesecev).

Če imate izkušnje na področju upravljanja kakovosti, uživate pri delu z ljudmi ter želite delati v dinamičnem in spreminjajočem se okolju multinacionalnega podjetja, vas vabimo, da nam pridružite pri našem poslanstvu.

Ključne odgovornosti in naloge:

• Vzdrževanje sistema kakovosti in skladnosti z zahtevami dobre distribucijske in dobre proizvodne prakse.

• Opravljanje aktivnosti, potrebnih za zagotavljanje in nadzor kakovosti pri sprejemu, shranjevanju, izdaji in transportu zdravil in medicinskih pripomočkov ter pregled nad dokumentacijo in zagotavljanjem sledljivosti serij.

• Obravnavanje pritožb na kakovost zdravil ter vprašanj v zvezi s kakovostjo zdravil.

• Obvladovanje GMP/GDP sprememb

• Obvladovanje GMP/GDP neskladnosti

• Obvladovanje dokumentacije v elektronskem dokumentacijskem sistemu.

Kdo ste:

• Vešč upravljanja kompleksnih sistemov in procesov s poudarkom na področju upravljanja kakovosti zdravil

• Odličen timski sodelavec v večfunkcionalnih skupinah

• Sposoben hitrega prilaganja nastalim spremembam ali pričakovanjimin

• Proaktiven in pozitivno naravnan

Izobrazba in zahteve:

• Magister farmacije.

• Zaželene so izkušnje na primerljivem delovnem mestu.

• Aktivno pisno in ustno znanje slovenskega jezika ter dobro pisno in ustno izražanje ter razumevanje v angleškem jeziku.

• Poznavanje orodij in programske opreme, kot je Google Workspace, MS Office ali podobno.

V podjetju Roche lahko najdete več kot le delovno mesto. Smo skupnost, ki ceni inovativnost, sodelovanje in zavezanost k ustvarjanju resničnih sprememb. Z vašim znanjem, izkušnjami in zavzetostjo lahko skupaj z nami ustvarjate dobre izkušnje, ki nas bodo še naprej odlikovale.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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