{"data":{"id":205775,"slug":"konstruktionsansvarig-for-api-och-ravaror","type":"job","title":"Design Authority for APIs and Raw Materials","description":"We are a growing company with approximately 1,000 employees in Sweden and over 40,000 employees worldwide. Our pride in our products permeates the entire organization. In our employee surveys, colleagues, development opportunities, and the family-friendly atmosphere are highlighted as some of the best things about working at Fresenius Kabi.\n\nBeing part of Fresenius Kabi is synonymous with being part of an environment with future prospects. We believe in our people and are passionate about developing all our employees. You have great opportunities to influence how that development unfolds.\nFresenius Kabi has also, for the fourth consecutive year, been designated as a Career Company and thus an attractive employer in Sweden thanks to our unique career opportunities.\nOur global organization means there is a wide variety of paths to choose from as part of your future development.\n\n1 position(s).\n\n\nWould you like to work with product quality in an international operation where your work contributes to medicines that improve and save lives? We are now seeking a Design Authority with a focus on active pharmaceutical ingredients (APIs), excipients, and other raw materials for the Tech Transfer & Product Lifecycle Management department.\nOperations Sweden is in an expansive phase with several ongoing and planned technology transfers to our facilities in Brunna and Uppsala. In this role, you will have broad responsibility for purchased and internally produced raw materials and will work closely with colleagues in production, quality, procurement, development, regulatory affairs, and project management \u2013 both in Sweden and internationally.\nAs Design Authority, you hold overall product technical responsibility for assigned APIs and raw materials throughout their lifecycle. You ensure that requirements, specifications, and documentation are scientifically sound, current, and compliant with applicable regulatory requirements and GMP.\nResponsibilities\n\n\u00b7 Ensure that specifications and other requirement documents for APIs and raw materials are fit for purpose, current, and meet applicable requirements.\n\u00b7 Evaluate new or changed APIs, excipients, raw materials, manufacturing processes, and supplier-related changes.\n\u00b7 Serve as Design Authority for APIs and raw materials in projects and contribute technical expertise to cross-functional project teams.\n\u00b7 Establish, review, and maintain regulatory CMC documentation with a focus on Module 3.\n\u00b7 Prepare supporting documentation and responses to questions from regulatory authorities regarding APIs and raw materials.\n\u00b7 Act as a subject matter expert in investigating and assessing deviations, change requests, risks, and other product quality issues.\nAbout You\n\n\u00b7 University degree in chemistry, pharmacy, chemical engineering, or another relevant natural science field, or equivalent competence through several years of relevant experience from the pharmaceutical industry,\n\u00b7 Experience working according to GMP\n\u00b7 Good ability to express yourself in speech and writing in Swedish and English.\nIt is advantageous if you have experience with APIs, excipients, or other pharmaceutical raw materials, CMC documentation and Module 3, regulatory change management, or qualification of suppliers and materials.\nTo succeed in this role, you are quality-conscious, analytical, and thorough. You take responsibility, drive matters independently, and collaborate well with others. You can structure complex information, make well-founded assessments, and communicate clearly with both internal and external contacts. You thrive in a changing environment where multiple issues need to be handled in parallel.\nYou will become part of a knowledgeable and engaged environment where quality, development, and responsibility go hand in hand. The role gives you the opportunity to work broadly with the product's and raw material's lifecycle, influence important quality decisions, and build an extensive network in a global organization.\nAbout the Position\n\n\u00b7 Employment type: Fixed-term employment until Dec 2027\n\u00b7 Location: Brunna\/Kungs\u00e4ngen outside Stockholm. Possibility to work from Uppsala. Travel between facilities occurs.\n\u00b7 Start date: By agreement, preferably as soon as possible.\nContact\nIf you want to know more about the position, you are welcome to contact recruiting manager Annika Wijk via email annika.wijk@fresenius-kabi.com.\nFor union representatives, you can email unionen-klubben@fresenius-kabi.com to contact Unionen and akademikerforeningen@fresenius-kabi.com to contact Akademikerf\u00f6reningen.\nWe warmly welcome your application via the link. We unfortunately do not accept applications via email or mail.\nSelection and interviews take place on an ongoing basis. The position may be filled before the final application deadline, so do not hesitate to submit your application today!\nOur recruitment process includes tests, interviews, reference checks, and background screening. At the interview, we ask you to present your degree certificate and relevant credentials. For the final candidate, a health screening will be conducted by our occupational health service.\n \nEmployment type: Fixed-term employment.\nDuration: 6 months or longer.","language":"sv","is_translated":true,"title_original":"Konstruktionsansvarig f\u00f6r API och r\u00e5varor","description_original":"Vi \u00e4r ett v\u00e4xande f\u00f6retag med cirka 1000 anst\u00e4llda i Sverige och \u00f6ver 40 000 anst\u00e4llda v\u00e4rlden \u00f6ver. V\u00e5r stolthet f\u00f6r v\u00e5ra produkter genomsyrar hela f\u00f6retaget. I v\u00e5ra medarbetarunders\u00f6kningar lyfts kollegorna, utvecklingsm\u00f6jligheterna och den familj\u00e4ra st\u00e4mningen upp som n\u00e5gra av de b\u00e4sta sakerna med att arbeta p\u00e5 Fresenius Kabi.\r\n\r\nAtt vara en del i Fresenius Kabi \u00e4r synonymt med att vara en del i en milj\u00f6 med framtidsutsikter. Vi tror p\u00e5 v\u00e5r personal och \u00e4r passionerad i v\u00e5r utveckling av alla v\u00e5ra medarbetare. Hur den utvecklingen ser ut har du stora m\u00f6jligheter att p\u00e5verka sj\u00e4lv.\r\nFresenius Kabi har dessutom, f\u00f6r fj\u00e4rde \u00e5ret i rad, blivit utsedda till Karri\u00e4rf\u00f6retag och d\u00e4rmed en attraktiv arbetsgivare i Sverige tack vare v\u00e5ra unika karri\u00e4rm\u00f6jligheter.\r\nV\u00e5r globala organisation medf\u00f6r att det finns en stor variation av v\u00e4gar att v\u00e4lja som ett led i din framtida utveckling.\r\n\r\n1 plats(er). \r\n\r\n\nVill du arbeta med produktkvalitet i en internationell verksamhet d\u00e4r ditt arbete bidrar till l\u00e4kemedel som f\u00f6rb\u00e4ttrar och r\u00e4ddar liv? Vi s\u00f6ker nu en konstruktionsansvarig med inriktning mot aktiva l\u00e4kemedelssubstanser (API:er), hj\u00e4lp\u00e4mnen och andra r\u00e5varor till avdelningen Tech Transfer & Product Lifecycle Management.\nOperations Sweden befinner sig i en expansiv fas med flera p\u00e5g\u00e5ende och planerade teknik\u00f6verf\u00f6ringar till v\u00e5ra anl\u00e4ggningar i Brunna och Uppsala. I rollen f\u00e5r du ett brett ansvar f\u00f6r ink\u00f6pta och egenproducerade r\u00e5varor och samarbetar n\u00e4ra med kollegor inom bland annat produktion, kvalitet, ink\u00f6p, utveckling, regulatoriska fr\u00e5gor och projektledning \u2013 b\u00e5de i Sverige och internationellt.\nSom konstruktionsansvarig har du det \u00f6vergripande produkttekniska ansvaret f\u00f6r tilldelade API:er och r\u00e5varor under hela deras livscykel. Du s\u00e4kerst\u00e4ller att krav, specifikationer och dokumentation \u00e4r vetenskapligt v\u00e4lgrundade, aktuella och f\u00f6renliga med g\u00e4llande regulatoriska krav och GMP.\nArbetsuppgifter\r\n\n\u00b7 Ansvara f\u00f6r att specifikationer och andra kravdokument f\u00f6r API:er och r\u00e5varor \u00e4r \u00e4ndam\u00e5lsenliga, aktuella och uppfyller g\u00e4llande krav.\n\u00b7 Utv\u00e4rdera nya eller f\u00f6r\u00e4ndrade API:er, hj\u00e4lp\u00e4mnen, r\u00e5varor, tillverkningsprocesser och leverant\u00f6rsrelaterade f\u00f6r\u00e4ndringar.\n\u00b7 Vara konstruktionsansvarig f\u00f6r API:er och r\u00e5varor i projekt samt bidra med \u00e4mnesexpertis i tv\u00e4rfunktionella projektteam.\n\u00b7 Uppr\u00e4tta, granska och underh\u00e5lla regulatorisk CMC-dokumentation med fokus p\u00e5 modul 3.\n\u00b7 Ta fram underlag och svar p\u00e5 fr\u00e5gor fr\u00e5n registreringsmyndigheter avseende API:er och r\u00e5varor.\n\u00b7 Fungera som sakkunnig vid utredning och bed\u00f6mning av avvikelser, \u00e4ndrings\u00e4renden, risker och andra produktkvalitetsfr\u00e5gor.\nOm dig\r\n\n\u00b7 H\u00f6gskole- eller universitetsexamen inom kemi, farmaci, kemiteknik eller annat relevant naturvetenskapligt omr\u00e5de, alternativt motsvarande kompetens genom fler\u00e5rig relevant erfarenhet fr\u00e5n l\u00e4kemedelsindustrin,\n\u00b7 Erfarenhet av arbete enligt GMP\n\u00b7 God f\u00f6rm\u00e5ga att uttrycka dig i tal och skrift p\u00e5 svenska och engelska.\nDet \u00e4r meriterande om du har erfarenhet av API:er, hj\u00e4lp\u00e4mnen eller andra farmaceutiska r\u00e5varor, CMC-dokumentation och modul 3, regulatoriskt f\u00f6r\u00e4ndringsarbete eller kvalificering av leverant\u00f6rer och material.\nF\u00f6r att lyckas i rollen \u00e4r du kvalitetsmedveten, analytisk och noggrann. Du tar ansvar, driver fr\u00e5gor sj\u00e4lvst\u00e4ndigt och samarbetar samtidigt v\u00e4l med andra. Du kan strukturera komplex information, g\u00f6ra v\u00e4lgrundade bed\u00f6mningar och kommunicera tydligt med b\u00e5de interna och externa kontaktytor. Du trivs i en f\u00f6r\u00e4nderlig milj\u00f6 d\u00e4r flera fr\u00e5gor beh\u00f6ver hanteras parallellt.\nDu blir en del av en kunnig och engagerad milj\u00f6 d\u00e4r kvalitet, utveckling och ansvar g\u00e5r hand i hand. Rollen ger dig m\u00f6jlighet att arbeta brett med produktens och r\u00e5varans livscykel, p\u00e5verka viktiga kvalitetsbeslut och bygga ett stort kontaktn\u00e4t i en global organisation.\nOm tj\u00e4nsten\r\n\n\u00b7 Anst\u00e4llningsform: Visstidsanst\u00e4llning till Dec 2027\n\u00b7 Placering: Brunna\/Kungs\u00e4ngen utanf\u00f6r Stockholm. M\u00f6jlighet att jobba fr\u00e5n Uppsala. Resor mellan anl\u00e4ggningarna f\u00f6rekommer.\n\u00b7 Tilltr\u00e4de: Enligt \u00f6verenskommelse, g\u00e4rna s\u00e5 snart som m\u00f6jligt.\nKontakt\r\nVill du veta mer om tj\u00e4nsten \u00e4r du v\u00e4lkommen att kontakta rekryterande chef Annika Wijk via mail annika.wijk@fresenius-kabi.com.\r\nF\u00f6r fackliga kontaktpersoner kan du mejla till\u00a0unionen-klubben@fresenius-kabi.com\u00a0f\u00f6r kontakt med Unionen och till\u00a0akademikerforeningen@fresenius-kabi.com f\u00f6r kontakt med Akademikerf\u00f6reningen.\nVarmt v\u00e4lkommen med din ans\u00f6kan via l\u00e4nken. Vi tar tyv\u00e4rr inte emot ans\u00f6kningar via e-mail eller post.\r\nUrval och intervjuer sker l\u00f6pande. Tills\u00e4ttning kan komma att ske innan sista ans\u00f6kningsdag, tveka inte att skicka in din ans\u00f6kan redan idag!\nI v\u00e5r rekryteringsprocess ing\u00e5r tester, intervjuer, referenstagning samt bakgrundskontroll. Vid intervju ber vi dig uppvisa examensbetyg och relevanta intyg. F\u00f6r slutkandidat genomf\u00f6rs en nyanst\u00e4llningsunders\u00f6kning hos v\u00e5r f\u00f6retagsh\u00e4lsov\u00e5rd.\n\u00a0\nAnst\u00e4llningsform: Tidsbegr\u00e4nsad anst\u00e4llning.\r\nVaraktighet: 6 m\u00e5nader eller l\u00e4ngre.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":"Rapsgatan 7","full_address":null,"city":"Uppsala","country":"SE","latitude":59.8520701,"longitude":17.7188369},"metadata":{"region":"Uppsala l\u00e4n","duration":"6 m\u00e5nader eller l\u00e4ngre","employer":"Fresenius Kabi AB","postcode":"75174","positions":1,"profession":"Regulatorisk handl\u00e4ggare\/Regulatory affairs specialist","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","scope_of_work":"100\u2013100 %","working_hours":"Heltid","contact_person":"Annika   Wijk","employment_type":"full_time","occupation_field":"Naturvetenskap","employer_workplace":"Fresenius-Kabi AB, Fresenius Kabi AB","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":3,"bot_views_count":5,"ai_vendor_counts":{"other":1,"openai":1,"anthropic":1},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":null,"owner_email":"annika.wijk@fresenius-kabi.com","images":[],"published_at":"2026-09-10T14:15:01+00:00","expires_at":"2026-10-01T23:59:59+00:00","created_at":"2026-09-11T03:27:02+00:00","updated_at":"2026-09-15T02:58:14+00:00"}}