{"data":{"id":164682,"slug":"quality-compliance-specialist-till-unimedic-pharma","type":"job","title":"Quality & Compliance Specialist at Unimedic Pharma","description":"Quality & Pharmacovigilance Department is responsible for ensuring that people with special medical needs have access to medicines of the right quality.\nAt Unimedic Pharma, quality and compliance are an integral part of daily operations. As MAH (Marketing Authorisation Holder) for most of their product range, they bear direct responsibility for ensuring their products meet the requirements set for registered medicines \u2013 at every stage of the chain, from suppliers and wholesalers to end customers.\nIn the role of Quality & Compliance Specialist, you will work with a wide variety of QA tasks and help drive QA operations forward. The QA & PV department consists of three colleagues and operates across the Nordic region. They are now looking for a curious and driven QA Specialist who likes to take responsibility and collaborate.\nAbout the Role\nAs a Quality & Compliance Specialist, you will have a broad and operational role where you contribute GMP and GDP expertise to the entire organization. You will work with GxP compliance and have close collaboration with external partners and CMOs. You will serve as dRP (deputy Responsible Person) by delegation and become a key person in ensuring that operations comply with applicable regulations, including GDP guidelines, EU Regulation 2021\/1248, and LVFS\/HSLF-FS for wholesale distribution.\nYou will work closely with the company's quality system \u2013 from managing and developing our eQMS to handling complaints, deviations, driving CAPA work, and conducting audits, often in dialogue with CMOs and other external partners. As part of the integration of XGX Pharma, you will also help shape how our quality systems are harmonized going forward.\nThe role includes, among other things:\nAct as deputy RP and ensure compliance with GDP and relevant regulations\n\n\nHandle complaints, investigate deviations, and drive CAPA work and risk assessments\n\n\nPlan and conduct audits and qualify and follow up on external partners\n\n\nParticipate in harmonizing quality systems as part of the XGX Pharma integration\n\n\nContribute with Regulatory Intelligence\n\n\nSupport onboarding of new partners\n\nAbout You\nWe are looking for someone who feels comfortable working independently and who thrives on taking own initiative and responsibility. The role carries a certain mandate, but it's not about always having the answers right away \u2013 rather about daring to make assessments and decisions based on the knowledge you have, and seeking support when needed. You like structure and clarity, and you prefer to drive issues all the way to completion rather than just handing them off and moving on.\nWe believe you:\nHave a natural science university degree, such as pharmacist, chemical engineer, or equivalent\n\n\nDocumented experience of independently making quality decisions in a GDP\/GMP environment with delegated quality responsibility\n\n\nAt least 5 years of experience in quality work with external manufacturers (CMOs) and\/or supplier and distribution chains, including qualification, quality agreements, deviation investigations, complaints, and audits\n\n\nExperience with quality processes in MAH operations, including PQR, recalls, and collaboration with Regulatory Affairs\n\n\nStrong knowledge of GDP and relevant regulatory requirements\n\n\nExperience developing and implementing quality systems and driving improvement initiatives at organizational level\n\n\nSpeak and write fluent Swedish and English\n\n\nYou have experience working in eQMS, GMP experience, and audit experience \u2013 as a participant or lead.\nWhy This Role & Unimedic Pharma?\nAt Unimedic Pharma, you will become part of a company in active growth, where the product portfolio is continuously expanded through acquisitions and long-term partnerships \u2013 most recently through the acquisition of Danish XGX Pharma. Our culture is built on the values of Curiosity, Courage, and Heart, which in our daily work means daring to improve processes, flagging deviations, and standing firm on quality matters.\nYou will have a broad mandate and the opportunity to grow into the role of Deputy over time, in an organization with short decision-making paths and a coaching rather than detailed management style. We believe that the combination of clear regulations and great personal responsibility suits you if you want to develop within QA in an international environment.\nApplication\nPlease submit your application as soon as possible. In this recruitment, Unimedic Pharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.","language":"sv","is_translated":true,"title_original":"Quality & Compliance Specialist till Unimedic Pharma","description_original":"Quality & Farmakovilgelans-avdelningen ansvarar f\u00f6r att s\u00e4kerst\u00e4lla att m\u00e4nniskor med s\u00e4rskilda medicinska behov f\u00e5r tillg\u00e5ng till l\u00e4kemedel av r\u00e4tt kvalitet.\nHos Unimedic Pharma \u00e4r kvalitet och regelefterlevnad en sj\u00e4lvklar del av vardagen. Som MAH (Marketing Authorisation Holder) f\u00f6r merparten av deras sortiment b\u00e4r de ett direkt ansvar f\u00f6r att deras produkter lever upp till de krav som st\u00e4lls p\u00e5 registrerade l\u00e4kemedel \u2013 i varje led av kedjan, fr\u00e5n leverant\u00f6rer och partihandel till slutkund.\nI rollen som Quality & Compliance Specialist kommer du jobba med stor variation av QA uppgifter samt vara med att driva QA-verksamheten fram\u00e5t. QA & PV-avdelning best\u00e5r av tre kollegor och jobbar Nordiskt, de letar nu efter en nyfiken och driven QA Specialist som gillar att ta ansvar och samarbeta.\nOm rollen\nSom Quality & Compliance Specialist f\u00e5r du en bred och operativ roll d\u00e4r du bidrar med GMP- och GDP-kunskap till hela organisationen. Du arbetar med GxP compliance och har ett n\u00e4ra samarbete med externa partners och CMO:er. Du agerar som dRP (deputy Responsible Person) enligt delegation och blir en nyckelperson i att s\u00e4kerst\u00e4lla att verksamheten lever upp till till\u00e4mpliga regelverk, bland annat GDP-riktlinjerna, EU-f\u00f6rordning 2021\/1248 samt LVFS\/HSLF-FS f\u00f6r partihandel.\nDu arbetar n\u00e4ra bolagets kvalitetssystem - fr\u00e5n att f\u00f6rvalta och utveckla v\u00e5rt eQMS till att hantera reklamationer, avvikelser, driva CAPA-arbete och genomf\u00f6ra audits, ofta i dialog med CMO:er och andra externa partners. I samband med integrationen av XGX Pharma f\u00e5r du dessutom vara med och forma hur v\u00e5ra kvalitetssystem harmoniseras fram\u00e5t.\nI rollen ing\u00e5r bland annat:\nAgera som deputy RP och s\u00e4kerst\u00e4lla efterlevnad av GDP och relevanta regelverk\n\n\nHantera reklamationer, utreda avvikelser samt driva CAPA-arbete och riskbed\u00f6mningar\n\n\nPlanera och genomf\u00f6ra audits samt kvalificera och f\u00f6lja upp externa partners\n\n\nDelta i harmoniseringen av kvalitetssystem i samband med integrationen av XGX Pharma\n\n\nBidra med Regulatory Intelligence\n\n\nSt\u00f6tta onboarding av nya partners\n\nOm profilen\nVi s\u00f6ker dig som k\u00e4nner dig bekv\u00e4m med att arbeta sj\u00e4lvst\u00e4ndigt och som trivs med att ta egna initiativ och att ta ansvar. Rollen inneb\u00e4r ett visst mandat, men det handlar inte om att alltid ha svaren direkt - snarare om att v\u00e5ga g\u00f6ra bed\u00f6mningar och ta beslut utifr\u00e5n den kunskap du har, och s\u00f6ka st\u00f6d n\u00e4r det beh\u00f6vs. Du gillar struktur och att saker blir tydliga och g\u00f6rs p\u00e5 r\u00e4tt s\u00e4tt, och du \u00e4r n\u00e5gon som g\u00e4rna driver fr\u00e5gor hela v\u00e4gen i m\u00e5l snarare \u00e4n att bara l\u00e4mna \u00f6ver och g\u00e5 vidare.\nVi tror att du:\nHar en naturvetenskaplig universitetsutbildning, till exempel som apotekare, kemiingenj\u00f6r eller motsvarande\n\n\nDokumenterad erfarenhet av att sj\u00e4lvst\u00e4ndigt fatta kvalitetsbeslut inom GDP\/GMP-milj\u00f6 med delegerat kvalitetsansvar\n\n\nMinst 5 \u00e5rs erfarenhet av kvalitetsarbete gentemot externa tillverkare (CMO) och\/eller leverant\u00f6rs- och distributionskedjor inklusive kvalificering, kvalitetsavtal, avvikelseutredningar, reklamationer och audits\n\n\nErfarenhet av kvalitetsprocesser inom MAH-verksamhet, inklusive PQR, recalls och samverkan med Regulatory Affairs\n\n\nHar god kunskap om GDP och relevanta regulatoriska krav\n\n\nErfarenhet av att utveckla och implementera kvalitetssystem samt driva f\u00f6rb\u00e4ttringsinitiativ p\u00e5 organisationsniv\u00e5\n\n\nTalar och skriver flytande svenska och engelska\n\n\nDu har erfarenhet av arbete i eQMS, erfarenhet av GMP, och erfarenhet av audits \u2013 som deltagare eller ansvarig (lead).\nVarf\u00f6r den h\u00e4r rollen & Unimedic Pharma?\nHos Unimedic Pharma blir du en del av ett bolag i aktiv tillv\u00e4xt, d\u00e4r produktportf\u00f6ljen kontinuerligt breddas genom f\u00f6rv\u00e4rv och l\u00e5ngsiktiga partnerskap \u2013 senast genom f\u00f6rv\u00e4rvet av danska XGX Pharma. V\u00e5r kultur b\u00e4rs av v\u00e4rdeorden Nyfikenhet, Mod och Hj\u00e4rta, vilket i v\u00e5r vardag handlar om att v\u00e5ga f\u00f6rb\u00e4ttra processer, flagga avvikelser och st\u00e5 p\u00e5 sig i kvalitetsfr\u00e5gor.\nDu f\u00e5r ett brett mandat och m\u00f6jlighet att med tiden v\u00e4xa in i rollen som Deputy, i en organisation med kort beslutsv\u00e4g och en coachande snarare \u00e4n detaljstyrande ledarstil. Vi tror att kombinationen av tydliga regelverk och stort eget ansvar passar dig som vill utvecklas inom QA i en internationell milj\u00f6.\nAns\u00f6kan\nSkicka in en ans\u00f6kan s\u00e5 snart som m\u00f6jligt. I denna rekrytering samarbetar Unimedic Pharma med SallyQ. Vid fr\u00e5gor, v\u00e4nligen kontakta Ellinor Crafoord, Senior Rekryteringskonsult, +46793554257 eller ellinor.crafoord@sallyq.se.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":"R\u00e5sundav\u00e4gen 12","full_address":null,"city":"Hagalund","country":"SE","latitude":59.363460951846,"longitude":18.020718046797},"metadata":{"region":"Stockholms l\u00e4n","duration":"Tills vidare","employer":"SallyQ AB","postcode":"16967","positions":1,"profession":"Kvalitetschef","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","employer_url":"https:\/\/sallyqab.teamtailor.com","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"Vanlig anst\u00e4llning","occupation_field":"Chefer och verksamhetsledare","employer_workplace":"SallyQ AB","translation_status":"done","experience_required":true},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":2,"ai_vendor_counts":{"anthropic":2},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":"+46793554257","owner_email":"ellinor.crafoord@sallyq.se","images":[],"published_at":"2026-08-20T13:20:37+00:00","expires_at":"2027-02-16T23:59:59+00:00","created_at":"2026-08-21T03:20:38+00:00","updated_at":"2026-08-21T04:01:36+00:00"}}