Specialist upravljanja kakovosti za področje skladnosti računalniških sistemov / QA eCompliance Specialist

Job Description Summary

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Location: Ljubljana, Slovenia
Vas zanima upravljanje kakovosti v farmacevtski industriji v povezavi s skladnostjo računalniških sistemov? Ste proaktivna in visoko motivirana oseba, ki si želi izzivov in tesnega timskega dela na globalnem nivoju? Imate izobrazbo tehnične ali druge primerljive smeri? Vas je vedno zanimalo kako izgledajo procesi v farmacevtski industriji? Ste natančna, zanesljiva in komunikativna oseba, ki si prizadeva za stalno profesionalno rast in išče priložnosti za napredovanje na naslednjo stopnjo v svoji karieri?
Če se najdete v zgornjem opisu vas vabimo, da se pridružite ekipi QA eCompliance na Novartisovi lokaciji v Ljubljani!
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Are you interested in quality management in the pharmaceutical industry in connection with computer system compliance? Are you a proactive and highly motivated person who seeks challenges and close teamwork at a global level? Do you have a technical education? Have you always been interested in how processes work in the pharmaceutical industry? Are you a precise, reliable, and communicative person who strives for continuous professional growth and seeks opportunities for advancement to the next level in your career?
If you identify with the above description, we invite you to join the QA eCompliance team at Novartis’ location in Ljubljana!

 

Job Description

Vaše ključne odgovornosti:

• Nudenje podpore pri dejavnostih za kvalifikacijo in validacijo računalniško podprtih sistemov (načrtovanje, svetovanje, pregled).
• Zagotavljanje implementacije veljavnih Novartisovih in regulatornih zahtev za področje GxP računalniško podprtih sistemov.
• Pregled / odobritev nadziranja sprememb v sistemu.
• Zagotavljanje kakovosti procesa v skladu s predpisi.
• Zagotavljanje strokovnega znanja oz. usmeritev za zagotavljanje kakovosti in ustreznosti GxP relevantnih računalniško podprtih sistemov, ocenjevanje dobaviteljev, nadzor nad spremembami, obvladovanje odstopov in povezanih aktivnosti, s čimer se zagotovi skladnost z regulatornimi predpisi in uresničijo pričakovanja podjetja.
• Pregledovanje in potrjevanje ocen opreme/sistemov glede GxP relevantnosti.
• Implementiranje in razvijanje novih zmogljivosti v skladu s poslovnimi potrebami.
• Priprava in podpora pri revizijah in inšpekcijskih pregledih.

Vaš doprinos k delovnem mestu:

• Visokošolska/univerzitetna izobrazba tehnične, računalniške ali druge naravoslovne smeri.
• Aktivno znanje angleškega jezika.
• Poznavanje orodja Microsoft Office.
• Minimalno 3 let delovnih izkušenj  s področja avtomatizacije/CSV in /ali avtomatizacije procesov in sistemov ter standardov s področja računalniških sistemov v farmacevtski industriji ali drugi ustrezni industriji.

Z izbranim kandidatom bomo sklenili delovno razmerje za določen čas 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.

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Key Responsibilities:

• Support site qualification and validation activities (planning, advising, review).
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure process quality assurance acc. to regulations.
• Ensure implementation of the applicable Novartis and regulatory requirements for GxP regulated computerized systems.
• Provide quality assurance expertise / guidance for GxP computerized systems classification, qualification, supplier assessment, change control, deviation management and associated activities that ensure compliance to regulatory and company expectations.
• Review and approve determination of  computerized system for GxP applicability.
• Adopts & develops new capabilities in alignment with Business needs.

Essential Requirements:

• University-level education in a technical, computer science, or other natural science field.
• Active knowledge of the English language.
• Familiarity with Microsoft Office tools.
• At least 3 years of work experience in the field of automation/CSV and/or process and system automation, as well as standards related to computer systems in the pharmaceutical industry or another relevant industry.

We offer temporary employment with 6 months of 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.

 

Skills Desired

Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Model